clinical engineering director

Barton HealthCare System

<div>***2 positions, 4-10's- Wednesday-Saturday and Sunday-Wednesday- 4-10's day shift***

***Actual offered hourly wage will depend on experience of the applicant***

Summary of Position:
The Clinical Engineer performs a variety of routine and complex tasks associated with the installation and maintenance of clinical equipment and clinical life safety criticality equipment. This role performs electrical safety tests on biomedical instrumentation using specialized test equipment, operates biomedical equipment and performs job related duties in a safe and efficient manner. This position is responsible for maintenance assignments that include and are not limited to general maintenance activities and repairs on electrical equipment, and all facets of biomedical and critical patient care and life safety care equipment throughout the organization. Work is performed at multiple healthcare systems.

 Qualifications

Education:
<ul>
<li>Associate&rsquo;s degree in Biomedical Equipment Technology or a related electronics field preferred.</li>
<li>High School or GED required</li>
</ul>
 Experience:
<ul>
<li>Minimum of 1 year recent work experience working with or training with a Clinical Engineering Team or equivalent combination of education and experience in the clinical engineering field.</li>
<li>Previous experience in a hospital or clinical setting, with a focus on a broad range of devices preferred.</li>
</ul>
Knowledge/Skills/Abilities:
<ul>
<li>Ability to demonstrate competency in the use and operation of all required test equipment.</li>
<li>Ability to interpret schematics, wiring diagrams and interpret drawings and specifications.</li>
<li>Working knowledge of physiology, anatomy, and medical terminology.</li>
<li>Sufficient computer skills required.</li>
<li>In compliance with patient safety standards, must be able to effectively communicate.</li>
<li>Knowledge of electronic circuitry and troubleshooting.</li>
<li>Ability to work with all levels of management and physician staff.</li>
</ul>
 Certifications/Licensure:
<ul>
<li>Manufacture certification on specified OEM medical equipment preferred.</li>
<li>Certified Biomedical Equipment Technician (CBET) preferred.</li>
<li>Valid California or Nevada driver&rsquo;s license or ability to obtain prior to start date.</li>
<li>Three-year DMV printout showing clean driving record.</li>
</ul>
 Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>While performing the duties of this job, the employee is frequently required to walk, stand, sit, and talk or hear.</li>
<li>The employee is occasionally required to use hands to finger, handle, feel or operate objects, tools, or controls; and reach with hands and arms.</li>
<li>The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl.</li>
<li>Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.</li>
<li>The employee must occasionally lift and/or move up to 25 pounds.</li>
</ul>
 Working Conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>Routine Hospital/Healthcare &amp; Office/Administrative conditions.</li>
<li>Contact with patients and guests under a wide variety of circumstances.</li>
<li>Regularly exposed to the risk of blood borne diseases.</li>
<li>Exposure to infections and contagious disease.</li>
<li>Exposed to hazardous anesthetic agents, body fluids and waste.</li>
<li>Subject to hazards of flammable and explosive gases.</li>
<li>Subject to varying and unpredictable situations, including the handling of emergency or crisis situations.</li>
<li>Subject to pressure due to irregular hours, frequent interruptions and stressful situations due to multiple demands.</li>
<li>Occasional travel to various health system locations.</li>
</ul>
Essential Functions
<div>
<ul><li>Provides consistently exceptional care at all times.</li></ul>
<ul><li>Maintains, repairs and installs medical equipment and systems.</li></ul>
<ul><li>Performs routine inspections, cleaning, and testing of medical devices to ensure compliance with safety standards and regulatory requirements (FDA, Joint Commission).</li></ul>
<ul><li>Diagnoses malfunctions and conducts repairs on electrical equipment, sterilizing equipment, and all facets biomedical equipment for the management of biomedical systems, including patient care equipment may include, beds, nurses call systems. Performs scheduled and unscheduled maintenance and electrical safety tests of biomedical equipment where applicable to maintain code compliance.</li></ul>
<ul><li>Maintains detailed, accurate records of all maintenance, repairs, tests, and service history in a maintenance management system.</li></ul>
<ul><li>Maintains accurate inventory of all biomedical equipment in the facility.</li></ul>
<ul><li>Manages inventory of spare parts and tools, and initiate purchase requests for needed supplies.</li></ul>
<ul><li>Educates nursing and medical staff on the proper operation, safety protocols, and daily care of equipment.</li></ul>
<ul><li>Responds to service calls in a timely fashion and may be required to respond to emergency codes, when applicable.</li></ul>
<ul><li>Responds to the needs of the department by performing other duties, as necessary.</li></ul></div></div>

Clinical Engineer- Full Time- 4-10's day shift

Bristol Myers Squibb

<div>Working with Us 
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. 
 
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 . 
 
The Associate Director, Cell Therapy Network CQV, is responsible for the network strategy for equipment/facility/utility Commissioning, Qualification, and Validation. The scope encompasses the internal CT manufacturing sites and engagement with external CMOs via Virtual Plant Teams. This role will partner cross-functionally with site CQV leads, site equipment owners, Cell Therapy network Digital Plant leaders, the BMS QMS Qualification Global Process Owner, and CTTO Global Equipment Owners. 
 
Key Responsibilities:<ul><li>
Establish strategy and deliver optimized and harmonized CQV approaches across the Cell Therapy network.</li><li>
Work collaboratively with Cell Therapy network Digital Plant and BMS enterprise qualification L2 to synthesize guidance in standards for qualification of equipment with internal computer systems.</li><li>
Oversight of Cell Therapy equipment validation execution across network, ensuring lifecycle management of the standardized approach.</li><li>
Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied, maintaining all sites in an inspection-ready status.</li></ul>
Qualifications &amp; Experience:<ul><li>
B.S., M.S., or Ph.D. in Mechanical Engineering, Chemical Engineering, or related scientific/engineering discipline with: 15+ years w/ B.S. or 12 years w/ M.S. or 8 years w/ Ph.D. of experience in biologics or cell therapy GMP manufacturing support.</li><li>
Strong understanding of CMC regulatory requirements, DS &amp; DP manufacturing, and analytical testing.</li><li>
Excellent strategic thinking, problem-solving, decision-making, and communication skills.</li><li>
Strong knowledge of ICH guidelines, control strategies, and validation lifecycle frameworks.</li><li>
Ability to effectively utilize project management and Lean Six Sigma tools is a plus.</li><li>
Excellent interpersonal, collaborative, team building, and communication skills.</li></ul>
#LI-Hybrid 
 
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.
 
 
Compensation Overview: 
 
Devens - MA - US: $175,750 - $212,973 
Madison - Giralda - NJ - US: $164,260 - $199,048 
Princeton - NJ - US: $164,260 - $199,048
 
Seattle - WA: $180,680 - $218,947 
 
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.
 
 
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/.
 
 
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>Health Coverage: Medical, pharmacy, dental, and vision care.</li><li>
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
</li><li>Financial Well-being and Protection: 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>Work-life benefits include:
 
 
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.
 
 
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. 
 
<ul><li>Eligibility Disclosure: 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> 
Uniquely Interesting Work, Life-changing Careers 
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. 
 
On-site Protocol 
 
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:
 
 
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.
 
 
Supporting People with Disabilities 
 
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.
 
 
Candidate Rights 
 
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
 
 
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/
 
 
Data Protection 
 
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 . 
 
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. 
 
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.
 
 
R1599924 : Associate Director, Cell Therapy Network CQV</div>

Associate Director, Cell Therapy Network CQV

Beth Israel Lahey Health

Boston, MA &bull; Beth Israel Deaconess Medical Center &bull; Full-time &bull; Day
 <div>When you join the growing BILH team, you're not just taking a job, you&rsquo;re making a difference in people&rsquo;s lives.

Reporting directly to the Chief Academic Officer, BILH/BIDMC, the Executive Director, Research Computing &amp; Informatics, provides strategic and operational leadership for research-focused IT services across the BILH system, with a primary emphasis on establishing, expanding, and sustaining a comprehensive High Performance Computing (HPC) program, AI/ML research capabilities and next generation cyber infrastructure for research. The Executive Director will partner closely with the BILH IT System Services Liaison for Research.

The Executive Director serves as a bridge between complex research IT capabilities and the academic community, with a demonstrated ability to communicate technical concepts, risks, and opportunities in clear, accessible terms to non-technical faculty, administrators, and senior leadership. This role partners closely with faculty, research leadership, academic units, and BILH IT System Services to enable data intensive, computational data, and AI-driven research across disciplines.
BILH is establishing a system-wide High-Performance Computing (HPC) Core enabled by a strategic grant from Dell Technologies. The Executive Director will lead the design, deployment, and operation of this enterprise HPC environment and ensure it delivers measurable impact across biomedical research, clinical trials, and AI-enabled healthcare.

This role is responsible for translating a major capital investment in advanced computing into a durable, secure, and investigator-focused capability. The Executive Director will bridge biomedical research, clinical informatics, AI governance, and enterprise IT, with an initial focus on AI-enhanced clinical trial recruitment and large-scale analysis of BILH-wide clinical and research data.

The position is foundational to BILH&rsquo;s strategy for data-powered precision medicine and will shape how computational resources are accessed, governed, and scaled across the system. 
The Executive Director serves as a key architect of the institution&rsquo;s research computational and AI research strategy, ensuring scalable, secure, and sustainable computing environments that enhance research competitiveness, attract external funding, and accelerate discovery by aligning capabilities with current and future research needs.

Job Description:

Key Responsibilities

Strategic Leadership &amp; Vision
<ul>
<li>Develop and lead a comprehensive strategy for research computing, HPC, and AI/ML platforms aligned with institutional research priorities and academic goals.</li>
<li>Translate institutional research priorities into computing capabilities supporting omics, imaging, clinical data analytics, simulation, and AI/ML workloads.</li>
<li>Establish a sustainable, scalable ecosystem for advanced computing and AI-enabled research, supporting modeling, simulation, data analytics, and machine learning workloads.</li>
<li>Advise the Chief Academic Officer and administrative leadership on trends, opportunities, and risks related to research IT, HPC, AI/ML, and cyberinfrastructure.</li>
<li>Integrate principles of responsible, ethical, and transparent AI into research computing strategy and operations.</li>
</ul>
HPC Core Leadership &amp; Delivery
<ul>
<li>Lead the implementation, operation, and continuous evolution of the HPC Core, ensuring enterprise-grade reliability, scalability, performance, and secure access.</li>
</ul><ul><li>Manage the HPC Core as a viable and sustainable service for the research community, balancing performance, access, and cost.</li>
<li>Establish governance, access models, service tiers, and support frameworks for shared HPC and AI/ML resources.</li>
<li>Promote best practices in research software engineering, reproducibility, workflow automation, and MLOps.</li>
</ul>
Clinical Trials &amp; AI Enablement
<ul>
<li>Drive early HPC and AI/ML use cases that strengthen clinical trial recruitment, including AI-enhanced cohort discovery and analytics.</li>
<li>Partner with clinical informatics and data teams to support large-scale querying and analysis of enterprise clinical datasets, including millions of patients, encounters, and clinical notes.</li>
<li>Ensure strict protection of PHI and regulated data through secure computing environments, governance controls, and compliance-aligned architectures.</li>
<li>Work closely with institutional AI/LLM governance bodies to ensure responsible, ethical, and compliant deployment of advanced analytics and AI workflows.</li>
</ul>
Research Engagement &amp; Enablement
<ul><li>Serve as the senior point of contact for investigators, core facilities, and translational research programs seeking advanced computational and AI-enabled support.</li>
</ul><ul><li>Ensure equitable access to HPC resources for early-stage investigators as well as large, data-intensive research programs.</li>
<li>Deliver early insights and demonstrable value from biomedical discovery and translational research use cases.</li>
<li>Support grant competitiveness by documenting HPC and AI/ML capabilities, advising on computational feasibility, and aligning infrastructure with sponsor expectations.</li>
<li>Establish and lead training and onboarding programs to enable effective researcher access and adoption of HPC and AI platforms.</li>
</ul>
Architecture, Operations &amp; Security
<ul>
<li>Oversee HPC and research computing architecture across on-premises, cloud, and hybrid environments, including GPU-accelerated systems.</li>
<li>Ensure enterprise-grade operations, including system monitoring, patching, lifecycle management, disaster recovery, performance tuning, and capacity planning.</li>
<li>Maintain close alignment with BILH IT System Services on facilities, power, cooling, networking, and physical and cyber security of high-value computing assets.</li>
<li>Promote best practices in research software engineering, reproducibility, workflow automation, and MLOps.</li>
<li>Oversee AI/ML research platforms, including data pipelines, model training and inference environments, high-performance storage, and research software ecosystems.</li>
<li>Establish governance, access models, service tiers, and support frameworks for shared HPC and AI/ML resources.</li>
<li>Promote best practices in research software engineering, reproducibility, workflow automation, and MLOps.</li>
</ul>
Governance, Strategy &amp; Partnerships
<ul>
<li>Contribute to institutional governance related to research computing, data science, and AI strategy.</li>
<li>Advise senior academic, research, and clinical leadership on trends, risks, and investment opportunities in HPC, AI/ML, and cyberinfrastructure.</li>
<li>Represent the institution in external initiatives and partnerships, including regional and national efforts such as the Massachusetts AI Hub.</li>
<li>Engage industry partners and vendors in ways that accelerate research while protecting patient data, institutional interests, and academic independence.</li>
</ul>
Financial &amp; Team Management
<ul>
<li>Manage HPC operating and capital budgets, vendor relationships, refresh cycles, and long-term capacity planning.</li>
<li>Implement transparent usage, allocation, and cost models that balance sustainability with broad and equitable access.</li>
<li>Build, mentor, and lead a multidisciplinary HPC and research computing team spanning infrastructure, storage, security, and investigator-facing support.</li>
<li>Foster a culture of collaboration, service excellence, and continuous learning.</li>
<li>Oversee AI/ML research platforms, including data pipelines, model training and inference environments, high-performance storage, and research software ecosystems.</li>
<li>Establish governance, access models, service tiers, and support frameworks for shared HPC and AI/ML resources.</li>
</ul>
Required Qualifications
<ul>
<li>Advanced degree (PhD, MD, or equivalent experience) in a computational, biomedical, engineering, data science, or other data-intensive discipline.</li>
<li>Leadership experience directing high-performance or large-scale research computing in an academic medical center or comparable environment.</li>
<li>Demonstrated experience supporting data-intensive biomedical and clinical research and working directly with investigators.</li>
<li>Strong understanding of secure computing environments for sensitive, regulated, or clinical data (e.g., PHI).</li>
<li>Proven ability to communicate complex technical concepts clearly and effectively to non-technical faculty, clinical leaders, and executive stakeholders.</li>
<li>Demonstrated success leading cross-functional teams and complex, enterprise-scale initiatives.</li>
</ul>
Desirable Qualifications
<ul>
<li>Direct experience of biomedical research activities.</li>
<li>Direct experience with AI/ML or LLM-based systems applied to clinical or translational research.</li>
<li>Experience integrating research computing platforms with EMR-adjacent or clinical data systems.</li>
<li>Track record of contributing to institutional infrastructure strategy or large-scale research initiatives.</li>
<li>Familiarity with governance models for AI, data access, and enterprise research computing.</li>
</ul>
The Executive Director must be able to:

<ul><li>Convert Dell&rsquo;s in-kind investment into real scientific and clinical impact.</li>
<li>Navigate the boundary between research computing and clinical data without compromising security or trust.</li>
<li>Deliver early wins in biomedical research, clinical trial recruitment and AI-enabled analytics while building a long-term, scalable platform.</li></ul> 


Pay Range:
$225,000.00 USD &ndash; $295,000.00 USD

The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.

<h2 class="jobSectionHeader">As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.</h2>

<h2 class="jobSectionHeader">More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.</h2>

<h2 class="jobSectionHeader">Equal Opportunity Employer/Veterans/Disabled</h2></div>
 <div><h3 class="jobSectionHeader">Job details</h3>
<ul><li><div>Employment: Full-time</div></li>
<li><div>Hours/Week: 40</div></li>
<li><div>Shift: Day</div></li>
<li><div>Category: General Information Technology</div></li>
<li><div>Pay Range: $225,000.00 USD - $295,000.00 USD</div></li>
<li><div>FLSA: Exempt</div></li>
<li><div>Req ID: JR92242</div></li></ul></div>

Executive Director, Research Computing and Informatics

Corbus Pharmaceuticals

<div>Description: 
The Director, Clinical Quality Assurance, reporting directly to the Senior Director, Head of Quality, will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Corbus sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Corbus Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following clinical QA areas: Vendor Quality, QA audit program, Corbus quality systems, and internal/clinical study team support.
The Director, Clinical QA will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness with regards to all quality requirements, and regulatory standards while supporting continuous clinical supply and delivery expectations. The ideal candidate will be based in the Boston area with 3 days in office in Norwood, MA.
Essential Functions and Duties:<ul><li>
Work collaboratively with the internal Corbus Clinical Operations Team to ensure compliance standards are achieved.</li><li>
Manage the GCP Quality interface and support for all Clinical Project Teams.</li><li>
Identify and access compliance risk and develop and implement risk mitigation measures.</li><li>
Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.</li><li>
Review and approve Clinical SOPs.</li><li>
Develop and Implement Clinical QA SOPs.</li><li>
Develop and implement detailed audit plans and yearly GCP audit schedules.</li><li>
Ensure the timely and effective follow up of all identified or assigned quality issues.</li><li>
Conduct QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.</li><li>
Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.</li><li>
Direct and/or deliver yearly GCP training for internal staff as needed.</li><li>
Work closely with Clinical Development, Clinical Operations, and other clinical functions/departments to ensure compliance readiness.</li><li>
Provide leadership in inspection preparedness to clinical sites and vendors for regulatory government agencies.</li><li>
Provide management reports on audit strategy, plans, and findings</li><li>
Support process improvement initiatives; lead continuous improvements within Quality.</li><li>
Maintain knowledge of GCP regulations, guidelines, company standards and procedures.</li><li>
Preferred experience in providing oversight and supporting GLP related studies</li></ul>
Requirements:

Education and Experience:<ul><li>
12+ years relevant work experience within the GxP (GCP heavy) Biotechnology/Pharmaceutical industry.</li><li>
Scientific or engineering degree (BSc, MSc, PhD), Min Bachelor of Science Degree in Biology, Biomedical Engineering, Engineering, or equivalent</li></ul>
Knowledge, Skills, and Abilities:<ul><li>
Knowledge of Good Clinical Practice (GCP) FDA, MHRA and EMA regulatory requirements applicable to Biologics therapy products.</li><li>
Very good scientific and medical/clinical expertise.</li><li>
Solid expertise in GCP and ICH clinical requirements, clinical development and methodologies of clinical studies.</li><li>
Effective communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.</li><li>
Must have ability to utilize knowledge and interpersonal skills to provide direction and development cross-functionally and regionally, at all organization levels</li><li>
Well organized and detail-oriented; must be able to effectively prioritize work</li><li>
Eager to learn, interact cooperatively and effectively with others in a team environment</li><li>
Possess advanced word processing, data entry and data presentation computer skills</li><li>
Ability to influence and work effectively with business partners across regions and cultures</li><li>
Displays organizational leadership qualities and effective coaching abilities.</li><li>
Listening, interpreting, and summarizing information skills must be highly developed.</li><li>
Ability to work both independently with direction and within project teams to attain goals.</li><li>
Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs).</li><li>
Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.</li><li>
Strong organizational skills and the ability to participate effectively cross-functionally.</li><li>
Ability to build consensus among colleagues with an appropriate level of flexibility, while maintaining a focus on results and goal attainment.</li><li>
Fluency in written and spoken English. Fluency in Chinese is a plus.</li><li>
Demonstrated ability to lead on-site corporate, external, or Health Authority inspections</li><li>
A self-starter and a team player who thrives in a fast-paced dynamic team environment.</li><li>
Proficiency in using Veeva Clinical and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint). Veeva Quality is a plus.</li></ul>
LICENSES/CERTIFICATIONS:<ul><li>
Certification as an auditor by an organization recognized is desirable within the pharmaceutical industry.</li></ul>
TRAVEL REQUIREMENTS:<ul><li>
Willingness to travel to various meetings/audits, may include overnight trips. Some international travel may be required.</li><li>
May require approximately 10-25% travel</li></ul>
Corbus Culture:
Corbus is a close-knit team of high-achieving, innovative, creative and, above all else, passionate employees. We hire for personality as well as for skill. At Corbus, we take pride in our &ldquo;family&rdquo; atmosphere where each person&rsquo;s contribution is vital to our success. As a Corbus employee, you are empowered to think creatively and be proactive in your approach. There is no place for politics or red tape here.
About Corbus;
Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focused on oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer</div>

Director, Clinical Quality Assurance (GCP)

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10000 clinical engineering director jobs Near Me

Clinical Engineer- Full Time- 4-10's day shift

Associate Director, Cell Therapy Network CQV

Associate Director, Cell Therapy Network CQV

Associate Director, Cell Therapy Network CQV

Associate Director, Cell Therapy Network CQV

Executive Director, Research Computing and Informatics

Director, Clinical Quality Assurance (GCP)