Senior Associate, Gene Therapy Quality Assurance

Company: Sarepta Therapeutics, Inc.
Location: Andover
Posted on: January 27, 2023

Job Description:

The QA Senior Associate is primarily responsible for quality oversight and guidance of in-house testing facilities with additional supporting oversight for contract testing labs. The Senior Associate will be a key member of QA team and oversee the quality systems to be developed and approved for implementation in the testing operations. In addition, they 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:Actively participates as a member of the Quality Ops Team and partners with the Quality Control and analytical team.Support Testing Operations during batch production and disposition, ensuring unexpected events are handled compliantly and in a timely manner.Review and approve documents including testing documentation in support of product disposition and stability; Standard Operating Procedures.Monitor and report metrics and manage routine measurement.Perform data review, analysis, identification of trends, and complex problem solving.Assist with problems of diverse scope using a high degree of judgment and risk-based decision makingApprise senior management of critical issues.Champion process improvement concepts.Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.Support a state of continuous inspection readinessMay work directly and build cross-functional relationships with Engineering, Facilities, Analytical Development and Regulatory.Desired Education and Skills: BS/MS in Biology discipline and 8+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations. Experience in setting up GMP operations and systems in new facility is beneficial.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, and the ability to read, write, speak, understand and to be understood in English.This position requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.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.#LI-JL1

Keywords: Sarepta Therapeutics, Inc., Boston , Senior Associate, Gene Therapy Quality Assurance, Other , Andover, Massachusetts