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 Principal will be responsible for oversite of day to day activities for multiple CMOs relative to product disposition including review of batch records and testing data, maintain applicable tracking and metric logs, attend CMO meetings, and general QA support for deviations and investigations and CAPA activities. This individual will be responsible for projects/objectives that will have significant impact on business unit and immediate organization. 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.The Opportunity to Make a Difference
Review of batch records, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing LaboratoriesPerforms lot disposition as applicableTracks/maintains metric logs related to lot release and deviations/investigationAttends CMOs meetings as applicable to ensure resolution of batch record review comments or questionsSupports Supply Chain during qualification and validation activities and batch production, ensuring unexpected events are handled compliantly and in a timely manner.Represents QA on project teams as requiredAssisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at SareptaSaves approved documents to the QA files and, provide applicable approval documentation to CMOs.Assists with SOP writing and other QA activities as requiredParticipates in external audit program as needed.Actively participates as a member of the Quality Ops Team and partners with the technical and analytical team.Performs data review, analysis, and identification of trends.Apprises senior management of critical issues.Supports a state of continuous inspection readiness.Works directly with Manufacturing, Engineering and Facilities on qualification and validation activities as applicable.More about You
BS/MS or relevant/equivalent industry experience in scientific discipline preferred and 8 years of experience in a cGMP environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewingExcellent organizational, interpersonal and communication skillsElectronic Quality Management Systems (eQMS) knowledgeDemonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirementsExperience in implementation and maintenance of quality systemsAble to exercise judgment to determine appropriate corrective actionsCandidate 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%What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.