Sr. Manager, QA Compliance

Sarepta Therapeutics•Andover, MA

3d•Hybrid

About The Position

The Sr. 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 Sarepta’s commercial products. This position will be responsible for oversight of the Sarepta Product Recall process along with executing the Annual Mock Recall.

Requirements

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.
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

Nice To Haves

Combination Drug compliance a plus.

Responsibilities

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
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.
Support Regulatory Inspections, Regulatory Submissions, Internal/External audits
Support Observation response management from Regulatory Inspections, Regulatory Submissions, Internal/External audits
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 Sarepta’s commercial products.
Member of Joint Signal Detection (JDST) meetings.
Generates metrics for Product Complaints and Change Controls to support JDST.
Author, review, and approval of GMP Controlled Documents including Sarepta Quality Manual and Quality Compliance Policies/Procedures.