Lead, QA Ops, Finished Goods

The Lead will be responsible for day to day activities related to product disposition including review of batch records and testing data, maintain applicable tracking and metric logs, attend CMOs meetings, general QA support for deviations and investigations and CAPA activities. In addition, he/she will be responsible for ensuring Sarepta’s quality policies, practices, procedures standards, and systems for necessary adherence to aseptic production and product management in accordance to the cGXP compliance to US, ATMP and EU regulations are being maintained.

Primary Responsibilities include:

• Review of batch records, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories
• Perform lot disposition as applicable
• Track/maintain metric logs related to lot release and deviations/investigation
• Attend CMOs meetings as applicable to ensure resolution of batch record review comments or questions
• Represent QA on project teams as required
• Assisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at Sarepta
• Scans approved documents to the QA files and, provide applicable approval documentation to CMOs.
• Assist with SOP writing and other QA activities as required
• Participate in external audit program as needed.
• Actively participates as a member of the Quality Ops Team and partners with the technical and analytical team.
• Perform data review, analysis, and identification of trends.
• Apprise senior management of critical issues.
• Support a state of continuous inspection readiness.
• Work directly with Manufacturing, Engineering and Facilities on qualification and validation activities as applicable.

Education and Skills Requirements:

• BS/MS or relevant/equivalent industry experience in scientific discipline preferred and a minimum of 8 years of experience in a cGMP environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing
• Excellent organizational, interpersonal and communication skills
• Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements
• Experience in implementation and maintenance of quality systems
• Able to exercise judgment to determine appropriate corrective actions
• Candidate will be expected to interact CMOs and other groups across Sarepta.
• Detail oriented and the ability to communicate effectively, proactively and professionally to clients and members of the management team.
• Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures.
• Excellent written & verbal communication skills.
• Ability to travel domestically and internationally less than 10%

#LI-Remote

This position is remote. However, 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.

The targeted salary range for this position is $112,000 - $140,000 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.

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.