Senior Manager, QA Compliance

Why Sarepta Why Now

The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers
  

For a full list of our comprehensive benefits see our website: Importance of the Role

The Senior Manager QA Compliance maintains GxP quality systems processes and procedures to drive quality compliance and business efficiencies. This position will work cross functionally with quality assurance operations quality control manufacturing validation Manufacturing Science &Technology (MS&T) and external vendors to gather analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g. Product Quality Review Quality Event Trending clinical manufacturing in process and release/ stability data laboratory controls data) to address adverse trends/ gaps as part of continuous improvement. This position will be responsible for tracking management and completion of Product Complaints as related to Sareptas commercial products. This position will be responsible for oversight of the Sarepta Product Recall process along with executing the Annual Mock Recall.

The Opportunity to Make a Difference

Responsibilities & Duties:

• Compliance Management:

• Responsible for tracking management and completion of cross functional areas Quality Records (such as deviations lab investigations change control complaints and CAPA) in partnership with applicable SMEs and leads error prevention and continuous improvement initiatives based on identified recurring root cause
• Maintain Quality Metrics and Key Performance Indicators (KPIs) in support of the quality record trending program.
• Owns and executes Quarterly/Annual trending of Quality records to identify adverse trends/risks to drive continuous improvement. Escalates to Quality Review Board as applicable.
• Monitors analyzes and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time

• Risk Management

• Ensure the Quality Risk Management process is implemented in accordance with regulatory requirements (e.g. ICH Q9 GMP guidelines).
• Provides independent QA oversight for risk assessments across departments.
• Ensure that decisions (deviations CAPA changes controls LIRs) are supported by appropriate risk evaluations.

• Audit Management

• Support Regulatory Inspections Regulatory Submissions Internal/External audits
• Support Observation response management from Regulatory Inspections Regulatory Submissions Internal/External audits

• Commercial Product Management

• Owner and SME of the Product Recall process. Responsible for managing Product Recalls/Annual Mock Recall.
• Responsible for escalation of Quality Defects to Health Authority agencies (FAR BPDR) as applicable.
• SME of Product Complaint Management program including related quality documents and continuous improvement efforts.
• Responsible for tracking management and completion of Product Complaints as related to Sareptas commercial products.
• Member of Joint Signal Detection (JDST) meetings. Generates metrics for Product Complaints and Change Controls to support JDST.

• Document Management

Author review and approval of GMP Controlled Documents including Sarepta Quality Manual and Quality Compliance Policies/Procedures.

More about You

Qualifications & Skills:

• B.S. or B.A. degree (preferably in Life Science Health Science or Biology) and ten years relevant experience in the pharmaceutical or biopharmaceutical industry (e.g biologics) background and quality assurance (minimum of 5-10 years)
• Quality professional with 5 years of hands-on experience with increasing responsibility in a QA and/or Quality Engineering function
• Significant GMP experience in commercial products global experience
• Extensive knowledge of US GxP compliance regulations and industry practices as well as EU GMP requirements
• Extensive knowledge of Veeva GMP Quality Management System (QMS) oversight for compliance
• Experience tracking managing and completing of Product Complaints in a commercial environment. Combination Drug compliance a plus.
• Excellent communication and organizational skills as well as negotiation influencing and collaboration skills and demonstrated ability to work cross functionally across internal stakeholders
• Proficient in building consensus negotiating and escalating issues and risk management
• Good understanding of the importance and use of quality metrics
• US FDA/EU inspection experience (participating or leading)
• Excellent command of spoken and written English language; the ability to clearly express complex ideas verbally and in writing
• Ability to handle high pressure environment associated with meeting deadlines
• Independent: able to work with minimal supervision; demonstrate initiative and self-direction
• Ability to manage multiple concurrent projects and to deliver results accurately and on time
• Interpersonal skills including teamwork listening giving feedback giving instructions and conflict resolution

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Hybrid

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $136000 - $170000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including but not limited to education training experience external market conditions criticality of role and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.