Finished Goods Lead, PIP

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re 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: https://www.sarepta.com/join-us
 

The Importance of the Role

The Finished Goods Lead of Quality Assurance Operations would perform the person in plant oversight for Sarepta quality operations (for clinical and commercial) related to Gene Therapy CMOs. This person will oversee on site batch record review with on the floor support at the Philadelphia facility and perform product disposition activities. They would provide oversight of the contract manufacturing management of the Quality program and product distribution. The position works closely with Sarepta and CMO Quality organizations, Technical Operations, and Supply Chain to establish and maintain effective working relationships, assist in project timelines, address quality related matters, deviation/change control review and other quality related oversight as necessary.

The Opportunity to Make a Difference

• 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.

More about You

• 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
• 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