Senior Manager, QA Compliance

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

1. 1Compliance Management:

1. 2Responsible 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
2. 3Maintain Quality Metrics and Key Performance Indicators (KPIs) in support of the quality record trending program.
3. 4Owns and executes Quarterly/Annual trending of Quality records to identify adverse trends/risks to drive continuous improvement. Escalates to Quality Review Board, as applicable.
4. 5Monitors, analyzes, and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time

1. 6Risk Management

1. 7Ensure the Quality Risk Management process is implemented in accordance with regulatory requirements (e.g., ICH Q9, GMP guidelines).
2. 8Provides independent QA oversight for risk assessments across departments.
3. 9Ensure that decisions (deviations, CAPA, changes controls, LIRs) are supported by appropriate risk evaluations.

1. 10Audit Management

1. 11Support Regulatory Inspections, Regulatory Submissions, Internal/External audits
2. 12Support Observation response management from Regulatory Inspections, Regulatory Submissions, Internal/External audits

1. 13Commercial Product Management

1. 14Owner and SME of the Product Recall process. Responsible for managing Product Recalls/Annual Mock Recall.
2. 15Responsible for escalation of Quality Defects to Health Authority agencies (FAR, BPDR) as applicable.
3. 16SME of Product Complaint Management program including related quality documents and continuous improvement efforts.
4. 17Responsible for tracking, management, and completion of Product Complaints as related to Sarepta’s commercial products.
5. 18Member of Joint Signal Detection (JDST) meetings. Generates metrics for Product Complaints and Change Controls to support JDST.

1. 19Document Management