Senior Manager, Qc Testing Oversight Qa Operations

The Senior Manager, QC Testing Oversight QA Operations leads the quality operations (for clinical and commercial) related to Gene Therapy onsite testing. Strong background with Biologics testing/Analytical knowledge preferred. This role includes oversight of on-site testing laboratories and may include involvement with contract labs. Primary responsibilities include managing GMP quality control lab testing data review and lab investigations, deviations, and associated quality systems. Development, implementation and management of a robust compliant Quality program for internal testing oversight. The position works closely with the QC/AD organization, Technical Operations, Supply Chain and CMO sites to establish and maintain effective working relationships, assist in project time lines, technical transfers, and other duties as necessary.

• Developing, Implementing and improving the quality system for testing Drug Substance and Drug products on a variety of assays on material intended for use in Clinical Trials, as well as commercial use
• Managing Investigation activities, Corrective and Preventative Action activities, Change Control activities and providing general quality assurance support for the overall Quality System at Sarepta
• Evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate and approve these quality system elements
• Implementing a standard, metric-based testing and oversight program that facilitates data reporting
• Overseeing key functional, tactical and operational aspects of Sarepta QA internal testing oversight at the Andover site. This includes approval and oversight of QC activities associated with exceptions, CAPA, deviations, analytical oversight, change control requests and other documentation related to QC/AD operations
• Managing Deviations, Investigations, CAPAs & Change Controls

• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is required
• Excellent organizational skills; ability to work independently and in team environments; strong knowledge of FDA GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices; and experience training personnel on document control systems and Quality Assurance concepts
• Experience with Electronic Document and Quality Management Systems preferred
• Knowledge of various system and product regulatory requirements (ICH/ISO/cGMP/etc.)
• Self-motivated, ability to make independent and informed decisions
• Strong leadership, communication and influencing skills
• Bachelor’s Degree or higher in a scientific discipline preferred
• Minimum 8-10 years’ experience in a regulated industry required; in a Biologics Quality Assurance testing/lab oversight role preferred
• Experience in working within document control systems is preferred
• Able to build relationships with various functional and business leaders in order to drive change in their areas

#LI-HybridThe targeted salary range for this position is $132,000 - $165,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.