quality compliance manager

Hamilton County, Ohio

<div><div><div><b>Quality Assurance Compliance Manager (4749-39)</b></div>
<div></div><div><b>Deadline to Apply:</b></div>
<div>Open Until Filled</div>
<div></div><div><b>Work Location:</b></div>
 <div>River City Correctional Center<br>
3220 Colerain Avenue<br>
Cincinnati, OH 45225</div>
<div></div><div><b>Work Hours:</b></div>
<div>80 Hours Bi-Weekly</div>
<div></div><div><b>Starting Salary:</b></div>
<div>$ 26.00 an hour</div><br>
<div></div>
<div></div><div><b>Requirements (Education, Experience, Licensure, Certification):</b></div>
<ul><li>Bachelor&rsquo;s degree.</li>
<li>Experience in Quality Assurance, measuring standards and reporting on standards..</li>
<li>Possession of a valid Ohio Operator&rsquo;s Permit.
</li></ul><div></div><div><b>Job Duties (Summary):</b></div>
</div><div></div><ul><li>Serves as compliance officer for ODRC, ACA, PREA, Sex Offender audits. Ensuring documents are accurate and in compliance, policies are updated and facility achieves excellent outcomes from audits</li>
<li>Oversees file audits, peer review and all program-related quality assurance measures.</li>
<li>Manages a comprehensive training program for all RCCC staff as directed by the Executive Team.</li>
<li>Trains new RCCC employees in the policies and procedures and standards of the facility.</li>
<li>Performs needs assessment/analysis and determines the most cost efficient and effective training development methods available.</li>
<li>Collects statistical data and training outcome measures for ongoing reporting requirements.</li>
<li>Oversee the Behavior Management System outcome data.</li>
<li>Oversee quality assurance documentation and reports.</li>
<li>Serves as compliance officer for ODRC, ACA, PREA, Sex Offender audits. Ensuring documents are accurate and in compliance, policies are updated and facility achieves excellent outcomes from audits.</li>
<li>Serves as record keeper of client files and ensure proper storage of such.</li>
<li>May facilitate groups in emergency due to shortage of staff with DD approval.</li>
<li>Provides detailed monthly, quarterly and annual reports on facility outcomes, standards and measures.</li>
<li>Provides suggestions for improvements on record keeping, documentation, training and reporting.</li>
<li>Works with Executive Director to provide detail reporting on trends for improvement.</li>
<li>Attends trainings to identify best practice to implement at River City.</li></ul><br>
<div><br>
<br>
<b>Positions Supervised</b><br>
Interns<br>
<br>
<b>Knowledge, Skills and Abilities</b></div>
<ul><li>Thorough knowledge of the criminal justice system, agency policies and procedures, court procedures and operations, and intake procedures and operations.</li>
<li>Sound understanding of effective correctional interventions, including cognitive-behavioral treatment.</li>
<li>Proven ability to adhere to curricula while demonstrating effective group facilitation skills.</li>
<li>Ability to communicate effectively, both to individuals and groups.</li>
<li>Ability to set goals, develop plans and execute evaluation process.</li>
<li>Knowledge of training media and instructional technologies.</li>
<li>Ability to maintain confidential and sensitive agency information.</li>
<li>Ability to operate standard office equipment such as computer and facsimile machine.</li>
<li>Visual ability sufficient to effectively operate office equipment such as copier and computer.</li>
<li>Ability to remain calm in tense situations.</li>
<li>Exceptional skills in oral and written communication.
</li><li>Ability to read and prepare reports with recommendations, correspondence, instructions, policies and procedures.</li>
<li>Ability to operate media equipment.</li>
<li>Knowledge of ACA and ODRC standards.</li></ul><br>
<div><br>
<br>
<b>Working Conditions</b><br>
Moderate noise in Correctional Facility setting.<br>
<br>
<br>
<b>Physical Demands</b></div>
<div>Work involves a significant amount of standing, walking, sitting, talking, listening, stooping and reaching with hands and arms; viewing computer screens and typing.<br>
<br>
<br>
<b>Communications</b><br>
Coneys and receives information in person and over the telephone.</div></div>

Quality Assurance Compliance Manager (4749-39)

Bristol Myers Squibb

<div><b>Working with Us</b><br>
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
<br>
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
<br>
<b>Position Summary</b><br>
<br>
The Manager, Lab Compliance (GLP &amp; Bioanalysis) ensures quality oversight and compliance leadership for all GLP and bioanalytical laboratory activities supporting nonclinical and clinical development. This role ensures robust, compliant lab services and data integrity across internal and external CROs laboratories, including vendor qualification and performance monitoring. The position ensures audit readiness, global regulatory inspections, and continuous improvement initiatives, partnering cross-functionally to support the organization's pipeline and business objectives. Additionally, this role supports compliance to bioanalysis AI/automation, risk-based oversight frameworks, and enterprise-level quality governance to meet evolving global expectations.<br>
<br>
<b>Position Responsibilities</b><br>
<br>
GLP &amp; Bioanalysis Compliance Oversight<ul><li>
Partner with Bioanalytical Scientists to optimize strategic direction for quality oversight of GLP and bioanalytical activities, including toxicology, PK, and ADA biomarkers.</li><li>
Maintain GLP quality systems, SOPs, and training programs.</li><li>
Ensure compliance with global regulatory standards (FDA, EMA, OECD, ICH) and internal quality requirements.</li><li>
Partner with Lab Quality for risk-based oversight of internal labs and external CROs, including qualification, audits, and compliance monitoring.</li><li>
Support the primary Bioanalytical Lead contact for regulatory inspections and audit hosts.</li><li>
Ensure scientific integrity and regulatory compliance with regards method development, validation, and sample analysis for bioanalytical studies (e.g., LC-MS/MS, ELISA, qPCR),</li><li>
Ensure study protocols, reports, and regulatory submissions, adhere to GLP standards.</li><li>
Drive resolution of deviations, CAPAs, and change controls across internal and external labs, ensuring timely and effective corrective actions.</li><li>
Implement robust documentation and data integrity practices across all testing sites, including archiving and audit readiness.</li><li>
Collaborate with procurement and quality teams to ensure CRO contracts include clear compliance expectations and deliverables.</li><li>
Support enhancements of structured performance dashboards, risk trending analytics, and formal governance forums.</li></ul>
Cross-Functional Collaboration<ul><li>
Partner with Bioanalysis, Nonclinical Safety, Clinical Pharmacology, Clinical Pharmacometrics, Translational Science, Clinical Development, Regulatory Affairs, and Lab Quality Assurance teams.</li></ul>
Continuous Improvement &amp; Training<ul><li>
Experience leading organizational change initiatives related to GLP modernization, digital transformation, or global quality harmonization.</li><li>
Lead training and competency programs for laboratory staff and stakeholders.</li><li>
Mentor and develop junior staff, fostering a culture of quality and compliance.</li></ul><b>
Qualifications &amp; Experience</b><br>
<br>
<b>Degree Requirements: </b>Bachelor's degree in a relevant scientific discipline required; advanced degree (MS, PharmD, PhD) strongly preferred.<br>
<br>
<b>Experience Requirements:
</b><ul><li>Minimum 4-5 years of lab compliance, bioanalysis, or related experience in pharma, biotech, or medical device industries.</li><li>
Experience managing global compliance programs, CRO governance, and digital quality system implementation strongly preferred.</li></ul><b>
Key Competency Requirements
</b><ul><li>Strong knowledge in GLP and bioanalytical laboratory compliance and global quality standards and regulations, including:<ul><li>
GLP (OECD, ICH M10)</li><li>
GCP (ICH E6)</li><li>
GMP (21 CFR Parts 210/211)</li><li>
GDP (Good Documentation Practice)</li><li>
FDA Quality System Regulation (21 CFR Part 58))</li><li>
IVDR (In Vitro Diagnostic Regulation) for EU compliance</li><li>
Data Integrity principles (ALCOA+)</li></ul></li><li>
Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions.</li><li>
Experience with digital quality systems such as LIMS/ELN, eQMS, audit-management platforms, and data integrity tools.</li><li>
Ability to facilitate risk assessments, enterprise risk mitigation strategies, and risk-based sampling/testing plans.</li><li>
Preferred certifications: RQAP-GLP, ASQ CQA, or other recognized compliance qualifications.</li><li>
Communication &amp; Collaboration: Skilled in translating scientific and compliance concepts into clear, actionable insights for cross-functional teams. Builds partnerships across internal and external stakeholders in matrixed environments to drive alignment and shared success.</li><li>
Influence &amp; Decision Making: Demonstrates personal accountability and ability to facilitate collaboration in cross functional teams in making timely, high-quality regulatory decisions that balance innovation, compliance, and enterprise impact.</li></ul>
Travel: Up to 20%<br>
<br>
#LI-Hybrid<br>
<br>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
<br>
<br>
<b>Compensation Overview:</b><br>
<br>
Princeton - NJ - US: $107,630 - $130,419
<br>
<br>
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
<br>
<br>
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
<br>
<br>
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
<ul><li><b>Health Coverage:</b> Medical, pharmacy, dental, and vision care.</li><li>
<b>Wellbeing Support:</b> Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
</li><li><b>Financial Well-being and Protection:</b> 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
</li></ul><b>Work-life benefits include:
</b><br>
<br>
Paid Time Off
<ul><li>US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
</li><li>Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
</li></ul>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
<br>
<br>
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.<br>
<br>
<ul><li><b>Eligibility Disclosure: </b>T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
</li></ul><br>
<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
<br>
<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
<br>
<br>
<b>Supporting People with Disabilities</b><br>
<br>
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
<br>
<br>
<b>Candidate Rights</b><br>
<br>
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
<br>
<br>
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
<br>
<br>
<b>Data Protection</b><br>
<br>
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .<br>
<br>
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.<br>
<br>
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
<br>
<br>
R1600504 : Manager Bioanalysis - GLP Lab Compliance</div>

Manager Bioanalysis - GLP Lab Compliance

Louisiana Organ Procurement Agency

<div>Description:
<p><b>
Job Title: Quality Compliance Auditor</b></p><p><b>
Department: Quality</b></p><p><b>
Reports to: Director of Quality</b></p><p><b>
Exemption: Full-Time, Non-Exempt</b></p><p><b>
Location: Onsite - Covington, LA. (Hybrid schedule with 2 WFH after orientation)</b></p><p><b>
Position Summary</b></p><p>
The Quality Compliance Auditor supports LOPA&rsquo;s compliance efforts through managing occurrence and deviation processes, designing and executing internal audits, and coordinating external audit readiness activities. This role evaluates organizational adherence to policies, procedures, and applicable regulatory standards, and collaborates with leadership to identify areas for improvement and ensure sustained compliance and audit preparedness.</p><p><b>
Essential Functions</b></p><ul><li>
Must be able to effectively operate Google suite applications as well as learn and adopt computer skills to effectively update and communicate within programs such as LOPA&rsquo;s referral management software and quality management software and hospital electronic medical records systems.</li><li>
Must be able to effectively and professionally communicate via different media, including, but not limited to, verbal, written and digital media. Communication may be both for internal and external audiences.</li><li>
Must be able to utilize current organizational resources to determine next steps in the process.</li><li>
Must be capable of executing LOPA&rsquo;s occurrence and deviation procedures to ensure adherence to company and industry standards.</li><li>
Must be capable of independently assessing occurrence and deviation reports to determine an appropriate course of action.</li></ul><p><b>
Job Role Expectations</b></p><ul><li>
 Through the occurrence and deviation processes and internal audits, supports the Director of Quality in assessing regulatory compliance of all agency processes.</li><li>
Analyzes occurrence and audit findings to recommend processes for targeted improvements.</li><li>
Designs materials for, and takes lead in the performance of, comprehensive preparations for audits by CMS, FDA, OPTN, and external partners.</li><li>
Develops, conducts, and documents internal audits to monitor adherence of process performance to process expectations and adherence of process performance to standards.</li><li>
Manages the occurrence and deviation process.</li><li>
Collaborates with leadership to develop action plans that prevent reccurrence of occurrence and audit findings.</li><li>
Establishes and maintains a monitoring system to assess the effectiveness of implemented preventative action plans.</li><li>
Uses fundamental quality tools including Flowchart, PDSA and RCA..</li></ul><p><b>
Organizational Expectations</b></p><ul><li>
Uphold LOPA core values of selfless, authentic and passionate.</li><li>
Use constructive and positive communication.</li><li>
Be a team player.</li><li>
Hold yourself and others accountable.</li><li>
Keep a positive attitude.</li><li>
Be respectful of others.</li><li>
Timely completion of all required educational training and tasks by assigned due date.</li><li>
Support the training of other employees as needed.</li></ul><p><b>
Work Environment</b></p><ul><li>
Possible exposure to communicable diseases, bloodborne pathogens, airborne illnesses, hazardous materials, pharmacological agents with little likelihood of harm if established health precautions are followed.</li><li>
May, at times, have exposure to blood, packaged organs and tissues for transplant and/or research in a hospital setting or while in the office.</li><li>
Work is done indoors in an office setting.</li></ul><p><b>
Physical Demands</b></p><ul><li>
Sedentary work that primarily involves sitting, some opportunities for standing work</li></ul><p>
and breaks.</p><p><b>
Work Hours</b></p><ul><li>
Full time, standard office hours. No expectation of overtime.</li></ul>
Requirements:<p></p><p><b><br>
Education and Experience</b></p><ul><li>
Bachelor&rsquo;s degree in Health Information Management, Business, Health Sciences, or a related field.</li><li>
Advanced coursework in Quality Management preferred; OR more than four years</li><li>
of related experience/training; OR an equivalent combination of education and experience.</li></ul><p><b>
Key Aspects of the Role</b></p><ul><li>
Strong foundation in Quality Assurance (QA), Performance Improvement (PI), and</li><li>
Regulatory Compliance.</li><li>
Experience applying continuous improvement principles and monitoring outcome measures.</li><li>
Ability to collect, interpret, and analyze data to inform decision-making and demonstrate impact.</li><li>
Proficient in developing, interpreting, and communicating numerical data.</li><li>
Knowledge of medical terminology and familiarity with healthcare structures, systems, and services.</li><li>
Skill in building and maintaining effective working relationships with internal teams and external partners.</li><li>
Skilled at presenting information effectively in both one-on-one and small group settings.</li><li>
Ability to read, write, and clearly interpret instructions, correspondence, and reports.</li><li>
Proficiency with standard office applications (e.g., email, word processing, spreadsheets); CRM or database experience a plus.</li><li>
Capacity to adapt to a dynamic, fast-paced environment while maintaining attention to detail.</li><li>
Commitment to confidentiality, ethical practice, and upholding LOPA&rsquo;s core values.</li><li>
Strong written and verbal communication skills, with the ability to connect across diverse audiences.</li><li>
Strategic thinking skills to align daily work with organizational goals and the broader mission.</li><li>
Ability to read, write and comprehend instructions, short correspondence, and memos.</li><li>
Ability to effectively present information in one-on-one and small group situations.</li><li>
Ability to develop, interpret and present numerical data.</li><li>
Ability to apply common sense understanding and to solve problems.</li></ul></div>

Quality Compliance Auditor

Iambic Therapeutics

<div>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 This role leads Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization&rsquo;s growing pipeline. The role partners closely with Regulatory, Medical, Clinical, R&amp;D, and Technology leadership to ensure quality systems enable innovation, maintain compliance, and support continuous inspection readiness across U.S. and global clinical programs.
 <br/>
 <br/>
 This job is based in San Diego, CA, or can be remote, and based in the US
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Lead the design, implementation, and ongoing effectiveness of the Quality Management System (QMS)
  </li>
  <li>
   Establish policies, procedures, and governance frameworks covering core quality processes, including document control, change management, deviations, CAPA, training, and risk management
  </li>
  <li>
   Act as a strategic quality partner to Regulatory, Medical, Clinical Operations, R&amp;D, and CMC teams
  </li>
  <li>
   Define and execute a quality roadmap that translates regulatory and quality requirements into practical, scalable operating models aligned with current compliance needs and future organizational growth
  </li>
  <li>
   Partner with Regulatory and Clinical teams to ensure quality systems support global clinical trial programs, including alignment across regions.
  </li>
  <li>
   Proactively identify and mitigate compliance risk through data-driven monitoring and governance
  </li>
  <li>
   Define key quality metrics and dashboards to monitor system health, compliance trends, and continuous improvement opportunities
  </li>
  <li>
   Foster a culture of accountability, transparency, and quality ownership across the organization
  </li>
  <li>
   Provide quality oversight and coordination for health authority interactions, internal audits, and third-party audits, as applicable
  </li>
  <li>
   Ensure inspection readiness for U.S. and global clinical programs through established quality systems, governance, and cross-functional alignment
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 Education &amp; Experience:
 <br/>
 <br/>
 <ul>
  <li>
   Bachelor&rsquo;s degree in chemistry, biology, engineering, or related health science
   <br/>
   <br/>
  </li>
 </ul>
 Experience:
 <br/>
 <br/>
 <ul>
  <li>
   10+ years of progressive experience in Quality Systems, Compliance, and/or Quality leadership within a regulated industry
  </li>
  <li>
   Experience designing, implementing, or improving Quality Management Systems
  </li>
  <li>
   Experience leading initiatives, projects, or teams in matrixed or growing organizations
  </li>
  <li>
   Experience partnering with cross-functional teams, including Regulatory, Medical, Clinical Operations, R&amp;D, and Technology
  </li>
  <li>
   Strong understanding of risk-based quality systems and continuous improvement concepts
  </li>
  <li>
   Ability to define and use quality metrics to monitor system performance and compliance trends
  </li>
  <li>
   Clear, effective communicator with the ability to influence and align stakeholders
  </li>
  <li>
   Comfortable operating in environments with evolving processes and priorities.
  </li>
  <li>
   Experience with electronic quality management systems (eQMS); Veeva experience a plus
  </li>
  <li>
   Familiarity with global regulatory expectations applicable to clinical development, including U.S. and international considerations.
  </li>
  <li>
   Working knowledge of GCP and applicable GMP principles as they relate to clinical quality systems
  </li>
  <li>
   Experience supporting inspection readiness, audits, or regulatory interactions through quality systems and cross-functional collaboration
  </li>
  <li>
   Demonstrated ability to translate regulatory and quality requirements into practical, scalable processes
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  About Iambic Therapeutics
  <br/>
  <br/>
 </strong>
 Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.
 <br/>
 <br/>
 MISSION &amp; CORE VALUES
 <br/>
 <br/>
 Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
 <br/>
 <br/>
 <strong>
  Pay And Benefits
  <br/>
  <br/>
 </strong>
 We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
 <br/>
 <br/>
 Compensation Range: $196K - $245K
 <br/>
 <br/>
</div>


Head of Quality Assurance

Integrated Resources, Inc ( IRI )

<div>
 <p>
  Our Team:
 </p>
 <p>
  The R&amp;D Global Quality Organization Genomic Medicine Unit (GQO GMU) team is responsible for external partner management, providing quality oversight of Client-sponsored GMP manufacturing and testing of genomic medicines at third parties. This position will join a collaborative team dedicated to ensuring phase-appropriate manufacturing excellence while maintaining strong partnerships with Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs).
 </p>
 <p>
  <br/>
 </p>
 <p>
  Main responsibilities:
 </p>
 <p>
  &bull; Support timely review of GMP documentation and ensure alignment with quality and regulatory expectations prior to release and/or approval (batch records, analytical data/specifications, validation protocols/reports, deviations, change controls, CAPAs, etc.).
 </p>
 <p>
  &bull; Maintain organization of project deliverables for external partner project using applicable tools.
 </p>
 <p>
  &bull; Identify, communicate, and mitigate quality risks in a pro-active and collaborative manner maintaining the business interests of Client and consideration of suitable outcome for the projects.
 </p>
 <p>
  &bull; Participate in and support, or lead where appropriate, batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies.
 </p>
 <p>
  &bull; Develop trusting internal team partnerships to ensure highly collaborative project outcomes.
 </p>
 <p>
  &bull; Develop trusting partnerships with external partners to ensure they understand, respect, and implement Client&rsquo;s guidance on all Quality matters.
 </p>
 <p>
  &bull; Contribute to and review in the development of Quality Technical Agreements.
 </p>
 <p>
  &bull; Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s).
 </p>
 <p>
  &bull; Promote Quality excellence and Quality Culture as a Quality Culture Liaison.
 </p>
 <p>
  &bull; Lead and/or support the drive for consistency and continuous improvement.
 </p>
 <p>
  &bull; Make decisions that uphold ethical standards.
 </p>
 <p>
  &bull; Support site project implementations, as assigned.
 </p>
 <p>
  <br/>
 </p>
 <p>
  Experience:
 </p>
 <p>
  &bull; Experience in the pharmaceutical industry with a quality focus, including external partner/ CMO management
 </p>
 <p>
  &bull; Knowledge of Quality Systems and Quality Management programs
 </p>
 <p>
  &bull; Understanding of cGMP/ICH/FDA/EMA regulations, with background in regulations and guidance for drug substance/ drug product manufacturing and/or gene therapies
 </p>
 <p>
  &bull; Familiarity with Chemistry Manufacturing Controls (CMC) requirements
 </p>
 <p>
  &bull; Experience managing quality operations for manufacturing projects
 </p>
 <p>
  <br/>
 </p>
 <p>
  Soft skills:
 </p>
 <p>
  &bull; Outstanding interpersonal and communication skills, including presentation abilities
 </p>
 <p>
  &bull; Being a demonstrated team player with experience contributing to multi-disciplinary project teams
 </p>
 <p>
  &bull; Working effectively with minimal supervision while maintaining strong collaborative relationships
 </p>
 <p>
  &bull; Strong project management skills and ability to work well under pressure
 </p>
 <p>
  &bull; Being highly organized with excellent attention to detail
 </p>
 <p>
  &bull; Managing multiple priorities while maintaining high productivity
 </p>
 <p>
  &bull; Having the ability to influence across internal and external networks, including Development, Manufacturing, Engineering, Digital, Quality, Regulatory Affairs, and external partners
 </p>
 <p>
  <br/>
 </p>
 <p>
  Technical skills:
 </p>
 <p>
  &bull; Research &amp; Development activities and processes (specifically in a CMC related field)
 </p>
 <p>
  &bull; Experience with Gene Therapy/ ATMP processes (preferred)
 </p>
 <p>
  &bull; Experience with aseptic processing (preferred)
 </p>
 <p>
  &bull; Proficiency with quality management systems and documentation tools
 </p>
 <p>
  &bull; Experience with external partner audits and quality assessments
 </p>
 <p>
  &bull; Knowledge of Quality Technical Agreements
 </p>
 <p>
  <br/>
 </p>
 <p>
  Education:
 </p>
 <p>
  &bull; B.S. plus 4 years' experience in a pharmaceutical or GMP environment with at least 2 years being in a Quality related field
 </p>
 <p>
  <br/>
 </p>
 <p>
  Languages:
 </p>
 <p>
  &bull; English: Fluent professional practice
 </p>
</div>


Quality Assurance Specialist - GMP

West Pharmaceutical Services

<div></div><div><div><div><div><div>Requisition ID: 73877
</div></div></div></div><div><div><div><div>Date: Apr 13, 2026
</div></div></div></div><div><div><div><div>Location:
Jersey Shore, PA, US
</div></div></div></div><div><div><div><div>Department: Quality
</div></div></div></div><div><div><div><div>Description:<br>
<p></p><p><b>This i</b><b>s an onsite position requiring the team member to be onsite 5 days a week</b></p><br>
<p>
</p><p><b>Who We Are:</b></p>
<p>
At West, we&rsquo;re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West&rsquo;s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?</p><br>
<p>
</p><p>There&rsquo;s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.</p><br>
<p>
</p><p>We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
</p><div><div><div><h4 class="jobSectionHeader"><b>Job Summary</b></h4>
</div><div><ul><li>In this role, you will manage, coordinate and administer the site customer compliance program: customer audits, complaints, projects and initiatives for continuous improvements and customer specifications.
</li><li>Manage and support internal projects and ensure compliance with cGMP, applicable ISO requirements and company policies and procedures.</li>
</ul></div></div><div><div><h2 class="jobSectionHeader"><b>Essential Duties and Responsibilities</b></h2>
</div><div><ul><li>Manage and support internal and external customer audits
</li><li>Manage the customer complaint process, review/approve (where required) complaint reports to ensure investigations are complete and thorough and customer response letters are adequate
</li><li>Analyze data and provide reports and recommendations to management for continuous improvements
</li><li>Oversee Supplier Relationship Management (SRM) meetings with customers
</li><li>Manage and oversee internal and external customer projects/initiatives
</li><li>Review/approve customer specifications
</li><li>Manages cross functional team to that interfaces with internal and external customers .
</li><li>Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
</li><li>Exhibits regular, reliable, punctual and predictable attendance</li>
<li>Prepare weekly, monthly, and quarterly reports to trend quality performance
</li><li>Other duties as assigned based on business needs
</li><li>Ensure adherence to corporate Quality System requirements</li>
</ul></div></div><div><div><h2 class="jobSectionHeader"><b>Education</b></h2>
</div><div><ul><li>Bachelor&rsquo;s degree in science, engineering or related field or associate&rsquo;s degree with relative experience preferred or equivalent work experience</li>
</ul></div></div><div><div><h2 class="jobSectionHeader"><b>Work Experience</b></h2>
</div><div><div>
<div><ul><li><p>Minimum 3 years of progressive experience in Quality Assurance, Quality Control, or cGMP environment</p>
</li>
</ul></div></div><div><div><ul><li><p>At least 1 year experience in managing others preferred</p>
</li>
</ul></div><div><ul><li><p>At least 1 year experience in a customer-facing role preferred</p>
</li>
</ul></div></div></div></div><div><div><h2 class="jobSectionHeader"><b>Preferred Knowledge, Skills and Abilities</b></h2>
</div><div><ul><li>Previous employment within the pharmaceutical, Health Care or Food/Beverage manufacturing industry preferred</li>
</ul><ul><li>Understanding of working Quality Management System (QMS) preferred but not required.
</li></ul><ul><li>Experience with customer interface and meeting customer expectations</li>
</ul><ul><li>Experience with ISO 9001, 15378, cGMPs requirements
</li></ul><ul><li>Working familiarity with Project Management tools and Quality Risk Management</li>
</ul><ul><li>Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
</li></ul><ul><li>Support and contribute to Lean Sigma programs and activities towards delivery of the set target
</li></ul><ul><li>Able to comply with the company&rsquo;s safety policy at all times</li>
</ul><ul><li>Able to comply with the company&rsquo;s quality policy at all times.
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>Travel Requirements</b></h2>
</div><div><div>5%: Up to 13 business days per year</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Physical Requirements</b></h2>
</div><div><div>Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Additional Requirements</b></h2>
</div><div><ul><li>Ability to learn, understand, and remember normal tasks.</li>
<li>Ability to hear, speak, and understand conversation in English in a normal tone of voice.</li>
<li>Ability to see and read letters, numbers, characters, or symbols and identify colors.</li>
<li>Must maintain the ability to work well with others in a variety of situations.
</li><li>Must be able to multi-task, work under time constraints, problem solve, and prioritize.
</li><li>Must also be able to maintain confidentiality and resolve conflicts appropriately for role.</li>
<li>Ability to make independent and sound judgments.</li>
<li>Read and interpret data, information and documents</li>
<li>Analyze and solve simple to complex problems</li>
<li>Observe and interpret situations and offer guidance.</li>
<li>Learn and apply new information or new skills</li>
<li>Work under deadlines with constant interruptions</li>
</ul></div></div></div><p>
#LI-DJ1 #LI-ONSITE</p>
<p>
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.</p></div></div></div></div></div><p></p>

Supervisor, Quality Customer Compliance

Century Packing

<p><b>Descripci&oacute;n general y prop&oacute;sito de la posici&oacute;n:</b></p><ul><li>Cumplir con los requisitos del Sistema Integrado de Seguridad Alimentaria y Calidad.</li><li>Es responsable por la operaci&oacute;n del departamento de Control de Calidad y de asegurar la calidad e inocuidad alimentaria de los productos que van al consumidor mediante la implementaci&oacute;n de los reglamentos de las agencias reguladoras estatales, federales y las buenas pr&aacute;cticas de manufactura.</li><li>Apoyar y asignar recursos para el funcionamiento adecuado del sistema gerencial de seguridad alimentaria y calidad.</li><li>Responsable de todas las actividades de Calidad e Inocuidad de alimentos incluyendo la planificaci&oacute;n estrat&eacute;gica y t&aacute;ctica alineadas a la Compa&ntilde;&iacute;a.</li><li>Establece pol&iacute;ticas de calidad y control de riesgo para que los productos sean elaborados siguiendo las normas y especificaciones establecidas, las regulaciones de la industria y el gobierno.</li></ul><p><b>Requisitos:</b></p><ul><li>Bachillerato en Procesamiento de Alimentos, Qu&iacute;mica, Microbiolog&iacute;a o Ingenier&iacute;a Industrial.</li><li>M&iacute;nimo 5-7 a&ntilde;os de experiencia como Gerente de Calidad en Manufactura de Alimentos, o Industria y posici&oacute;n similar.</li><li>Experiencia previa en el manejo de Sistemas de Calidad (HACCP, FSSC 22000, ISO 22000).</li><li>Experiencia en an&aacute;lisis estad&iacute;sticos y de control (SPC, Cp y Cpk).</li><li>Completamente biling&uuml;e (ingl&eacute;s y espa&ntilde;ol).</li><li>Lean and Six Sigma training.</li><li>Disponibilidad para trabajar fines de semana, tiempo extra, d&iacute;as feriados. Caminar a trav&eacute;s de la planta, disponibilidad a trabajar en &aacute;reas calientes.</li></ul><p><i>Somos una empresa que ofrece igualdad de oportunidades en el empleo y no discrimina por razones de raza, sexo, edad, color, religi&oacute;n, origen nacional, incapacidad, condici&oacute;n de veterano o por motivo de violencia dom&eacute;stica, agresi&oacute;n sexual o acecho.</i></p><p>Benefits:</p><ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Health insurance</li><li>Life insurance</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

QA & Compliance Manager

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