Primary Responsibilities Include:

• Oversight and be accountable for key functional, tactical and operational aspects of Sarepta QA Operations at the Pennsylvania CMO site. This includes oversight, including approval of Packaging activities associated with exceptions, CAPA, deviations, change control requests/approvals and other documentation related to Packaging and QA operations
• Evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate and approve these quality system elements
• Partnering with Contract Manufacturing organizations (CMO) and Contract testing laboratories (as applicable)
• Support/Improve of the quality system for Lot Release and Disposition of Finished Goods intended for use in Clinical Trials, as well as commercial use.
• Oversee, review and suggest improvement initiatives based on performance metrics
• Monitor / Oversee Investigation activities, Corrective and Preventative Action activities, Change Control activities and providing general quality assurance support for the overall Quality System at Sarepta
• Assist with SOP writing and other QA activities as required.
• Support a state of continuous inspection readiness.
• Apprise senior management of critical issues.
• Participate/ Support in internal / external audit program as needed.

Desired Education and Skills:

• Bachelor's Degree or higher in a scientific discipline preferred
• Minimum 8 years' experience in a regulated industry required; in a Biologics Quality Assurance Lot Release role preferred
• Other requirements include: Excellent organizational skills; ability to work independently and in team environments; understanding 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
• 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
• Experience in working within document control systems is preferred
• Experience with Electronic Document and Quality Management Systems preferred
• Strong relationship management and communication skills in order to drive change
• Capable leader, able to influence and drive accountability
• Self-motivated, ability to make independent and informed decisions
• Knowledge of various system and product regulatory requirements (ICH / ISO / cGMP / etc)

This position will be a primary on site point of contact for Sarepta CMO Quality Assurance matters as a person in plant, located in Pennsylvania, preferably Philadelphia area. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of batch review and disposition while ensuring compliance with Sarepta / CMO procedures, process requirements, and regulatory standards.

Some Travel is required.

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

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.