clinical quality manager

Ecorgy Solutions Private Limited

<p><b>Responsibilities:</b></p><ul><li>Evaluate clinical procedures and documentation to identify areas for improvement, ensuring adherence to industry standards.</li><li>Conduct compliance audits and assessments to provide continuous improvement feedback and maintain industry compliance.</li><li>Prepare and engage in client audits, including regular mock audits, ensuring preparedness and compliance.</li><li>Stay updated on industry regulations, clinical guidelines, and best practices to ensure compliance and innovation.</li><li>Communicate quality-related issues and recommendations to stakeholders efficiently.</li><li>Engage in quality-focused training and educational programs for continuous professional development.</li></ul><p><b>Qualifications:</b></p><ul><li>BAMS/ BHMS/ BDS/ Pharm D</li><li>0-5 years of clinical or healthcare setting experience.</li><li>Profound knowledge of medical terminology and clinical processes.</li><li><b>Good computer skills (Typing speed, MS Excel/Word) </b>- Mandatory.</li><li><b>Excellent English communication</b>, written and verbal - Mandatory.</li><li>Willing to work in night shifts <b>(10:30PM to 7:30AM)</b> - Mandatory.</li></ul><p>Job Type: Full-time</p><p>Pay: &#8377;25,000.00 - &#8377;35,000.00 per month</p><p>Application Question(s):</p><ul><li>How many years of experience do you have?</li><li>Are you okay to work in night shifts (10:30PM to 7:30AM) on regular basis?</li><li>Are you located in Trivandrum or at commutable distance?</li><li>We must fill this vacancy urgently. Are you available immediately for joining?</li></ul><p>Work Location: In person</p>

Clinical Quality Manager - Doctors (Trivandrum)

Amgen

<div><p>Join Amgen&rsquo;s Mission of Serving Patients</p><p>
At Amgen, if you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. Our shared mission&mdash;to serve patients living with serious illnesses&mdash;drives all that we do.</p><p>
Since 1980, we&rsquo;ve helped pioneer the world of biotech in our fight against the world&rsquo;s toughest diseases. With our focus on four therapeutic areas &ndash;Oncology, Inflammation, General Medicine, and Rare Disease&ndash; we reach millions of patients each year. As a member of the Amgen team, you&rsquo;ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.</p><p>
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you&rsquo;ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.</p><p></p><p><b>
Quality Compliance Manager</b></p><p><b>
What you will do</b></p><p>
Let&rsquo;s do this! Let&rsquo;s change the world!</p><p>
We are hiring a Quality Compliance Manager, which will operate within the <b>General Medicine &amp; Obesity Quality Therapeutic Area.</b></p><p>
In this vital role you will provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program. (protocol development, database lock, and regulatory submissions/ approvals).</p><p>
Reporting to the Quality Compliance Associate Director, you will oversee quality management and ensure compliance for global and local clinical trials by supporting study teams and trial sites involved in Amgen-sponsored Trials.</p><p><b>
Responsibilities</b></p><ul><li><p>
GCP Subject Matter Expert - Provide independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.</p></li><li><p>
Provide quality oversight for Amgen programs for all stages of products in clinical development</p></li><li><p>
Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights</p></li><li><p>
Support the establishment of regional expertise to ensure quality and compliance to local Regulations</p></li><li><p>
Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management activities, and Serious Breaches/ Privacy Issues</p></li><li><p>
Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)</p></li><li><p>
Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes</p></li><li><p>
Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)</p></li><li><p>
Manage/support regulatory inspection and review responses.</p></li><li><p>
Prepare, analyze and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other significant quality information on periodic basis to key partners</p></li><li><p>
Support Monthly meetings with program level CPO senior management/associate directors to review, but not limited to, the following: ongoing quality issues, quality trends, program filing timelines and potential inspections.</p></li><li><p>
Support response generation for audit findings and self reported deviations.</p></li><li><p>
Support the establishment of regional expertise to ensure quality and compliance to local regulations</p></li><li><p>
Provide Study Specific Vendor Quality Oversight</p></li><li><p>
Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)</p></li></ul><p></p><p><b>
What we expect of you</b></p><p>
We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:</p><p><b>
Basic Qualifications:</b></p><ul><li><p>
Doctorate degree OR</p></li><li><p>
Master&rsquo;s degree and 2 years of quality management experience OR</p></li><li><p>
Bachelor&rsquo;s degree and 4 years of quality management experience OR</p></li><li><p>
Associate&rsquo;s degree and 8 years of quality management experience OR</p></li><li><p>
High school diploma / GED and 10 years of quality management experience</p></li></ul><p></p><p><b>
Preferred Qualifications:</b></p><ul><li><p>
Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility</p></li><li><p>
Oversight and implementation of <b>Quality Management Systems</b> and experience managing quality in electronic QMS such as Veeva or Track wise.</p></li><li><p>
Thorough understanding of <b>Clinical R&amp;D activities and Global Regulations.</b></p></li><li><p>
Knowledge of the <b>Regulatory Submission</b> and <b>Inspection Management</b> procedures.</p></li><li><p><b>
Quality Oversight of Clinical Trials</b>, including clinical trial protocol development, execution, and submissions.</p></li><li><p>
Excellent verbal and written communication skills, including strong business writing abilities and active listening.</p></li><li><p>
Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format.</p></li><li><p>
Strong analytical, critical-thinking, and decision-making abilities.</p></li><li><p>
Capability to understand and articulate technical concepts and literature in spoken and written <b>English</b>.</p></li></ul><p></p><p><b>
What you can expect from us
</b></p><p>As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we&rsquo;ll support your journey every step of the way.</p><p>
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.</p><p>
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:</p><ul><li><p>
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts</p></li><li><p>
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan</p></li><li><p>
Stock-based long-term incentives</p></li><li><p>
Award-winning time-off plans</p></li><li><p>
Flexible work models, including remote and hybrid work arrangements, where possible</p></li></ul><p></p><p>
Apply now and make a lasting impact with the Amgen team.</p><p><b>
careers.amgen.com</b></p><p>
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.</p><p></p><p>
Application deadline</p><p>
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.</p><p></p><p>
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.</p><p></p><p>
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.</p><p></p><p>
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</p></div>

Quality Compliance Manager

Novartis

<div><div><h3 class="jobSectionHeader"><b>Summary
</b></h3><div>Responsible for ensuring operational excellence related to clinical trial activities within Translational Clinical Oncology (TCO). Track progress to key quality indicators (KQIs), Quality Plan and overall compliance to applicable processes and regulations. Lead and assist in the development and implementation of process improvement initiatives within the function; ensure changes are adequately communicated and managed. Work collaboratively with clinical QA (CQA) and appropriate line functions to ensure that TCO upholds high quality standards.</div>
</div><div><h3 class="jobSectionHeader"><b>About the Role
</b></h3><div><p><b>Major accountabilities:
</b></p><ul><li>Accurate and timely execution of process improvement and quality initiatives as measured by meeting key milestones effectively.</li><li>
Successful implementation of process improvements as measured by sustainable changes and improved efficiency.</li><li>
Increased compliance with relevant processes.</li><li>
Establish business partnerships with all relevant TCO functional groups, CQA, training and other LFs as required.</li><li>
Training programs implemented in a timely fashion, and tracked to ensure compliance and maintenance</li></ul><h2 class="jobSectionHeader"><b>
</b><b>Impact on the Organization</b><b>:
</b></h2><ul><li>Improved quality of outputs</li><li>
Increased compliance with SOP, GCP and training</li><li>
Decreased audit/inspection findings</li><li>
Efficient use of resources through operational effectiveness</li></ul><h2 class="jobSectionHeader"><b>
Additional Details</b></h2><ul><li>
KQIs - Responsible to track, report and reinforce adherence to applicable performance measures. Support in recommending corrective actions based upon report outputs and root cause analysis; and support implementing training/communication as applicable to ensure remediation (preventative actions). Support Clinical Trial Quality Risk Management (CTQRM) review by evaluating studies to ensure adherence to CTQRM SOP and follow-up with respective study leads.</li><li>
SOPs - provide input into new SOPs/WPs on behalf of TCO as applicable, may serve as subject matter expert. Contribute to identifying training opportunities and ensuring compliance with new SOPs and Working Practices. Track quality issues and ensure their documentation within the quality event management system and implementation of corrective actions. Support the implementation and tracking of compliance to the clinical trial processes.</li><li>
Quality Plan - Ensure that actions required of TCO are appropriately tracked. Support the conduct of self-assessments for TCO in conjunction with CQA. Proactively ensure procedural deficiencies within TCO are corrected and prevented. Liaise with BR TM and CS&amp;I and appropriate Development LFs to ensure quality outcomes.</li><li>
Process Expertise &ndash; identify or support the identification of procedural gaps and their correction with process improvements where applicable. Represent TCO/BR in cross-functional initiatives aiming for continual process improvement and ensuring a compliance focused environment either by direct involvement or by ensuring appropriate TCO/BR representation. May serve as Managed Access Program Champion.</li><li>
Training -Support training/communications to assure understanding of new processes or findings. Assure remediation. Identify gaps and assign action where needed to promptly gain compliance. Assist with change management activities related to new processes or organizational changes. Support/organize timely Lessons Learned sessions.</li><li>
Compliance &ndash; As applicable based on assignment, ensure Corrective Actions Preventative Actions (CAPA) commitments are adequate, submitted and completed in a timely manner. Initiate and document root cause investigations of critical issues. Support inspection preparation and inspection readiness. Ensure the timely submission and completion of adequate Corrective Actions Preventative Actions (CAPA). Ensure audit and inspection outcomes requiring corrective action are managed.</li><li>
Act as TCO Protocol Review Committee Manager, as assigned: run PRC Office independently (meetings and agenda planning, uploading of documents in review system), maintain the PRC SharePoint site, system owner of the TCO PRC submission tracker, providing training and access and working with IT on system updates; maintain revisions to the PRC charter.</li><li>
Act as BR-DOC Manager, as assigned &ndash; manage end-to-end document QC function with BR Translational Medicine &ndash; BR Doc function. Provide vendor management, track submissions and provide guidance to TCO teams.</li><li>
As assigned, participate as a reviewer on the TCO Protocol Review Committee or assist with quality checks of documents (protocols, ICFs, etc) as appropriate per TCO process.</li><li>
Escalate issues to TCO management and CQA in a timely manner.</li></ul><p><b>
Minimum Requirements:
</b><br>
<b>Work Experience:
</b></p><ul><li>A minimum of 5 years of relevant pharmaceutical clinical development experience</li><li>
Extensive knowledge of clinical development process, GCP and clinical quality management; including strong understanding of regulation and guidance for clinical studies</li><li>
Proficiency/Fluency in English</li><li>
Experience working in matrix environment and in global teams.</li><li>
Excellent interpersonal, problem-solving, negotiation and conflict resolution skills</li><li>
Excellent organizational skills, as well as predisposition to quality management and process improvement</li><li>
Excellent communicator and presenter (oral and written).</li></ul><p></p><p><b>
Education:
</b></p><ul><li>Bachelor of Science (BS) or advanced degree in scientific discipline or equivalent education in life science/healthcare required</li></ul><p><b>
Languages :</b></p><ul><li>
English.</li></ul></div>
</div><div><div><p><b>Why Novartis:</b> Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients&rsquo; lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture</p><p><b>
Join our Novartis Network:</b> Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network</p><p><b>
Benefits and Rewards:</b> Read our handbook to learn about all the ways we&rsquo;ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards</p></div></div></div>
<br><div><div>Division
<div>Biomedical Research
</div></div><div>Business Unit
<div>Research
</div></div><div>Location
<div>India
</div></div><div>Site
<div>Hyderabad (Office)
</div></div><div>Company / Legal Entity
<div>IN10 (FCRS = IN010) Novartis Healthcare Private Limited
</div></div><div>Functional Area
<div>Research &amp; Development
</div></div><div>Job Type
<div>Full time
</div></div><div>Employment Type
<div>Regular
</div></div><div>Shift Work
<div>No
</div></div><div>
</div><div><h3 class="jobSectionHeader"><b>Accessibility and accommodation</b></h3><p>
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.</p>
</div><div><p>Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.</p></div></div><div></div>

Senior Process and Compliance Manager

Fresenius Medical Care

<div>
 <strong>
  Reporting To:
  <br/>
  <br/>
 </strong>
 Manager Clinical Quality, India
 <br/>
 <br/>
 <strong>
  Summary of Vacant Role:
  <br/>
  <br/>
 </strong>
 The responsible is to enhance the quality of care in the assigned clinic by providing guidance, subject matter expertise and support. This role also acts as liaison between hemodialysis clinics and other stake holders.
 <br/>
 <br/>
 <strong>
  Roles and Responsibilities
 </strong>
 <strong>
  :
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Implementation of Clinical Quality &amp; Management Directives and work instructions across assigned clinics.
  </li>
  <li>
   Implement documents are listed on the appropriate registers and that they reflect current best practices and are compliant with clinical directives.
  </li>
  <li>
   Ensuring all documents are appropriately managed with a register and version control and clinics are notified of all new documents.
  </li>
  <li>
   Reviews health records as necessary to assess and evaluate the appropriateness of care and treatment.
  </li>
  <li>
   Periodic Audits as per the Audit Calendar for the year.
  </li>
  <li>
   Need base Audit&rsquo;s.
  </li>
  <li>
   Prepare, Collate and report on CQ audits.
  </li>
  <li>
   Ensure 100% adherence to the Clinical Quality protocols.
  </li>
  <li>
   Focus on OHS &amp; EHS.
  </li>
  <li>
   Focus on EuCliD to achieve 100% compliance.
  </li>
  <li>
   Collaborates with other functional areas in the organization to ensure synergy and achieve Clinical Quality objectives.
  </li>
  <li>
   Strengthening of the link between Clinical Quality and clinical Nursing and education.
  </li>
  <li>
   Maintaining currency of knowledge and expertise in the designated functional areas of Quality.
  </li>
  <li>
   Maintains &amp; updates own knowledge in relation to Quality and Infection Prevention and Control.
  </li>
  <li>
   Avails and utilizes personal, corporate and other resources to maintain up-to-date knowledge of all aspects of treatment of end-stage renal disease.
  </li>
  <li>
   Participates in one or more courses in formal education and functional area related conferences to advance knowledge and qualifications.
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills, Qualifications and Experience Required:
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Registered Nurse/Allied Health Professional/Pharmacist or possessing similar health qualifications
  </li>
  <li>
   3-5 years&rsquo; experience in healthcare environment
  </li>
  <li>
   Knowledge of hemodialysis and experience in implementing and supporting teams in infection prevention and control activities
  </li>
  <li>
   Extensive experience in Public Speaking and delivering education
  </li>
  <li>
   Strong organizational and analytical skills
  </li>
  <li>
   Excellent verbal and written communication skills
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Characteristics Required:
  <br/>
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Ability to work within a multidisciplinary multicultural team.
  </li>
  <li>
   Strong leadership skills including customer service, performance management, education and continuous quality improvement, accreditation and infection prevention and control.
  </li>
  <li>
   Sensitivity to and respect for individual and cultural differences
  </li>
  <li>
   Ability to self-motivate and work autonomously within the scope of the role.
  </li>
  <li>
   Ability to represent the organization in a professional manner and build and maintain effective relationships.
  </li>
  <li>
   Highly organized with proven experience in self-initiated projects and communication
   <br/>
   <br/>
   <br/>
  </li>
 </ul>
 Fresenius Medical Care is a global leader in providing high-quality healthcare solutions and services. We are committed to fostering an inclusive and diverse work environment where all employees are treated with respect and fairness, regardless of race, gender, caste, ethnicity, religion, disability, or any other characteristic. We believe in equal opportunities for all and celebrate diversity as a key driver of innovation and success. Our commitment to equality ensures that every individual has the opportunity to thrive
</div>


Assistant Manager - Quality Auditor

Lumos Pharma, Inc.

<div><div><b>Clinical Quality Assurance Specialist</b></div>
<div></div><div>Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.</div>
<div></div><div>This position reports to the Vice President, Quality and Compliance, and is responsible for providing quality oversight of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal quality systems and compliance functions. The Clinical Quality Assurance Specialist is expected to execute established processes involving quality assurance, quality systems, and compliance.</div>
<div></div><div>ESSENTIAL FUNCTIONS</div>
<ul><li>Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements</li>
<li>Provide input on protocol deviations and associated corrective/preventive actions involving clinical trials.</li>
<li>Perform audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)</li>
<li>Complete required tasks in the electronic quality management system</li>
<li>Assist with training coordination, ensuring employees are up to date on quality and compliance requirements</li>
<li>Assist with audits of external suppliers</li>
<li>Routinely work with internal and external stakeholders to achieve cross-functional goals.</li>
<li>Each employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing decisions and completing compliance training within the specified time frames.</li>
</ul><div><div><div>REQUIRED QUALIFICATIONS</div>
<div></div><div>Education</div>
<ul><li>Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, Chemistry, Health Administration, or related technical discipline</li>
</ul><div>EXPERIENCE</div>
<ul><li>1-3 years of experience in quality assurance within the pharmaceutical or biotech industry</li>
</ul>
<div></div><div>PREFERRED QUALIFICATIONS</div>
<ul><li>Knowledge of GMP and GCP regulations</li>
<li>Strong attention to detail, documentation accuracy, and organizational skills</li>
<li>Microsoft Office</li>
<li>Experience with MasterControl is desirable</li>
<li>Experience with CDER BIMO inspections is desirable</li>
</ul>
<div></div><div>COMPETENCIES</div>
<ul><li>Analytical Skills: Strong analytical skills with a strategic mindset for clinical development and commercialization.</li>
<li>Communication: Excellent communication skills, with the ability to clearly articulate complex scientific information to technical and non-technical audiences.</li>
<li>Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with internal and external stakeholders.</li>
<li>Business Acumen: Business acumen is the ability to understand and discriminate between various business-related topics and issues.</li>
<li>Decision-Making/Judgment: Decision-making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures.</li>
</ul>
<div></div><div>WORK ENVIRONMENT</div>
<div>This position can work remotely in the United States.</div>
<div></div><div>TRAVEL EXPECTATION</div>
<div>Up to 10%</div>
<div></div><div>What you can expect as a Lumosian</div>
<ul><li>Industry-competitive compensation</li>
<li>Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.</li>
<li>Lumos covers 85 &ndash; 95% of the medical premium</li>
<li>Health Reimbursement Arrangement</li>
<li>8 weeks of fully paid parental leave for all new parents</li>
<li>Gym or fitness class reimbursement</li>
<li>401(k) with 5% employer contribution</li>
<li>Flexible work hours and location</li>
<li>Generous PTO policy</li>
<li>11 paid holidays in the US</li>
<li>Offices in Austin, TX, and Ames, IA</li></ul></div></div></div><div></div>

Clinical Quality Assurance Specialist

Backpack Healthcare

<div><p><b>Manager of Quality and Compliance</b></p>
<p><b>
Position Qualifications:</b></p>
Must be actively licensed as a behavioral health professional (LCSW, LPC, LMFT, or equivalent) and have held such licensure in good standing for a minimum of four (4) years. This ensures the candidate meets supervision and compliance standards required for oversight under applicable state and accrediting body regulations.<br>
<ul><li><ul><li>
</li>
<li>Minimum <b>3 years of experience</b> in compliance, quality assurance, or clinical operations in a behavioral health or healthcare setting. <b>5+ years preferred</b><br>
</li>
<li>Experience with <b>CARF accreditation</b> (preparation, implementation, or maintenance) required.<br>
</li>
Demonstrated ability to build compliance programs from the ground up, including policies, audits, and training infrastructure.<br>
<li>
</li>
<li>Strong understanding of <b>HIPAA, 42 CFR Part 2, Medicaid, and multi-state behavioral health regulations</b>.<br>
</li>
Skilled in regulatory research, interpretation, and application across multiple states.<br>
<li>
</li>
Proficient in data analysis and quality improvement methodologies .<br>
<li>
</li>
</ul></li></ul><h3 class="jobSectionHeader"><b>How We Support You:</b></h3>
<p>
<b> </b><b>Growth &amp; Education</b> &ndash; CEU reimbursement, and advancement opportunities</p>
<p>
<b> Supportive &amp; Fun Team Culture</b> &ndash; Be apart of a community of clinicians &amp; operators</p>
<p>
<b>Competitive Benefits</b></p>
<ul>
<li>Medical, Dental &amp; Vision Insurance</li>
<li>401(k) + 3% Company Match</li>
<li>Paid Holidays &amp; PTO</li>
</ul>
<p>Backpack Health is an Equal Opportunity Employer. We believe that the strength of our care depends on the diversity and well-being of our team. We celebrate differences in age, color, disability, ethnicity, gender identity or expression, national origin, physical and mental ability, race, religion, sexual orientation, veteran status, and other traits that make each person unique. We welcome and encourage diverse candidates to apply for any position for which they are qualified and to bring their unique perspectives, experiences, and talents to our team.</p></div>

Manager of Quality and Compliance

HCA Healthcare

<p></p><div>This position is incentive eligible.<br>
<br>
<br>
<h5 class="jobSectionHeader"><b>Job Summary and Qualifications</b></h5><p></p><p>
The Division Director of Ambulatory Clinical Quality will serve as the lead subject matter expert for clinical quality and risk for all ambulatory locations and providers for HCA Physician Services. This will encompass providing oversight for the quality of care being provided by approximately 5,500+ providers in 1,100+ practice locations (unique divisions range from approximately 35 to 140 practice locations and 160 to 830 providers and may increase as acquisitions occur). The Division Director of Ambulatory Quality is responsible for leading a robust clinical quality, risk, government payor initiatives program, and performance improvement activity agenda that will span across all specialty service lines. The Division Director of Ambulatory Clinical Quality will collaborate very closely with operational leadership in order to achieve the clinical outcomes that support HCAs mission and vision.</p><p>
The Division Director of Ambulatory Clinical Quality role is based in Fort Lauderdale, Florida with some travel across the division and to headquarters in Brentwood, TN as needed.
</p><p>DUTIES INCLUDE BUT NOT LIMITED TO:</p><p></p><ul><li>
Provides strategic leadership to the clinical quality, risk and performance improvement agenda within the assigned division.</li><li>
Develops, in collaboration with the division operational leadership, a customized quality agenda specific to the market driven needs of the assigned division.</li><li>
Directs efforts to ensure effective clinical quality program and performance improvement implementation throughout the assigned Division(s). Provides guidance to HCA Physician Services employees/management in complying with the requirements and intentions of the program.</li><li>
Provides leadership to drive work for clinical improvement and service enhancement. Supports practices in preparation of meaningful reports to the HCA Physician Services Quality Committee, Division Leadership, Physician Governance Councils, and HCA Physician Services Vice Presidents.</li><li>
Acts as a support for HCA Physician Services Quality Improvement and Patient Safety initiatives, as directed. Prepares and submits minutes from all meetings; as directed.</li><li>
In coordination with the Clinical Services Group (CSG), develops and implements programs, initiatives, and improvement strategies to ensure consistency in compliance with applicable laws, regulations, and other governmental requirements. Ensures that required state/federal reporting is completed in a timely manner.</li><li>
Monitors and communicates with Operations regarding quality improvement trends. Assists in preparations of metric reports and development of meaningful improvement plans. Participates in Quality Monthly and Quarterly Operating Reviews.</li><li>
Facilitates effective communication with Physician Services and CSG leadership regarding key clinical performance improvement activities and initiatives.</li><li>
Responsible for facilitating investigation, required reporting, and corrective action development for serious quality or risk issues within the division as requested by Division Vice President and Group Vice President. Accesses company resources as appropriate. Facilitates completion of Root Cause Analysis.</li><li>
Maintains awareness of regulations, keeping abreast of pending and or implemented changes. Develops communication tools to alert Divisions.</li><li>
Participates in development of Division Quality Strategic Planning that takes into consideration local market dynamics.</li><li>
Maintains current competency with all current Quality Program initiatives.</li><li>
Provides practice assessments and identifies deficiencies as applicable, develops in collaboration with operations any needed corrective action plans, and assists in the management of the action plan to completion.</li><li>
Submits meaningful reports to the AVP outlining the Division&rsquo;s performance on quality initatives and provides action plan for any initiative not being met.</li><li>
Provides education to employees and Medical Staff and supports ongoing education related to Quality Program initiatives.</li><li>
Meets regularly with Practice Managers and encourages shared learning.</li><li>
Provides divisional support and leadership for all government payor initiatives including, but not limited to, the Medicare Access and Children&rsquo;s Health Insurance Program Reauthorization Act (MACRA), the Merit Based Incentive Payment System (MIPS), and as applicable advanced alternative payment models such as Accountable Care Organizations (ACOs) and Comprehensive Primary Care Plus (CPC)+.</li><li>
Reviews complaints, concerns, or questions relative to quality issues, and provide consultative leadership and support to practices and Division personnel as appropriate and as directed by Division Vice President and Group Vice President.</li><li>
Maintains the strictest confidentiality in the areas of patient, employee and physician relations.</li></ul><p></p><p>
EDUCATION &amp; EXPERIENCE:</p><p></p><ul><li>
Bachelor&rsquo;s Degree required, Master&rsquo;s Degree highly preferred</li><li>
3-7 years relevant experience required.</li><li>
Active RN license as required by state of employment</li></ul><p></p><h5 class="jobSectionHeader"><b>
Benefits</b></h5><p>
HCA Healthcare offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:</p><ul><li>
Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.</li><li>
Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.</li><li>
Free counseling services and resources for emotional, physical and financial wellbeing<br>
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401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)<br>
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Employee Stock Purchase Plan with 10% off HCA Healthcare stock<br>
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Family support through fertility and family building benefits with Progyny and adoption assistance.<br>
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Referral services for child, elder and pet care, home and auto repair, event planning and more<br>
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Consumer discounts through Abenity and Consumer Discounts<br>
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Retirement readiness, rollover assistance services and preferred banking partnerships<br>
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Education assistance (tuition, student loan, certification support, dependent scholarships)<br>
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Colleague recognition program<br>
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Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)<br>
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Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.</li></ul><p>
Learn more about Employee Benefits</p><p><i>
Note: Eligibility for benefits may vary by location.</i></p><p><br>
Our teams are a committed, caring group of colleagues. Do you want to work as a(an) Division Director of Ambulatory Clinical Quality where your passion for creating positive patient interactions is valued? If you are dedicated to caring for the well-being of others, this could be your next opportunity. We want your knowledge and expertise!</p><p>
<b>Physician Services Group</b> is skilled in physician employment, practice and urgent care operations. We are experts in hospitalist integration, and graduate medical education. We lead more than 1,300 physician practices and 170+ urgent care centers. We are HCA Healthcare's graduate medical education leader. We provide direction for over 260 exceptional resident and fellowship programs. We focus on carrying out value-added solutions. These solutions help physicians deliver patient-centered healthcare. We support HCA Healthcare's commitment to the care and improvement of human life.</p><p>
HCA Healthcare has been recognized as one of the World's Most Ethical Companies&reg; by the Ethisphere Institute more than ten times. In recent years, HCA Healthcare spent an estimated $3.7 billion in cost for the delivery of charitable care, uninsured discounts, and other uncompensated expenses.</p><p></p><p><br>
&quot;Bricks and mortar do not make a hospital. People do.&quot;- Dr. Thomas Frist, Sr.<br>
HCA Healthcare Co-Founder</p>
<p>If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Division Director of Ambulatory Clinical Quality opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. <b>Unlock the possibilities and apply today!</b></p><p><i>
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.</i></p></div>

Division Director of Ambulatory Clinical Quality

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