What are the responsibilities and job description for the Senior Manager, Quality Assurance position at Sarepta Therapeutics?
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
Reporting to the Director, Research & Clinical Development Quality Assurance, the Senior Manager, Research & Clinical Development QA, Audit Management will be responsible for monitoring and evaluating the compliance of clinical studies and Sarepta's oversight of studies to FDA and International regulations and guidelines, as well as corporate policies and standard operating procedures. The Senior Manager will participate in vendor risk assessment and vendor qualification, GxP audit consultation management, and the development of performance, quality and risk metrics. Investigator site and internal process audit coordination and execution are additional aspects of this role. This position will also participate in inspection readiness activities and audits, as appropriate.The Opportunity to Make a Difference
- Plans, prepares and conducts GLP/GCP/GVP audits of clinical investigators, nonclinical and clinical vendors and systems.
- Assists in the development of internal and external GLP/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities
- Ensures that audit results are formally and consistently recorded, conducted, reported and that appropriate corrective/preventive actions have been requested and documented
- Participates in the risk assessment of all new and current GxP vendors/CRO partners and conduct or coordinate vendor qualification audits/assessments as needed
- Ensures compliance of quality management system with applicable regulations, quality guidelines and standards
- Assists in the development and maintenance of GxP audit management processes and documentation including policies, SOPs and guidelines.
- Collaborates with Clinical Trial Team members to assess ongoing audit needs and provide GxP guidance to functional teams, and execute directed audits, where required.
- Participates in inspection readiness and preparedness activities (i.e., sponsor monitor, sites, etc.) and provide guidance and support for all GxP inspection activities
- Supports internal and external regulatory inspections and Inspection Readiness activities
- Coordinates and manages Audit Consultants as appropriate
More about You
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 8 years experience in a related industry
- 5 years experience in a Quality Assurance role, GLP/GCP/GVP, including both external and internal audits
- Experience working with and providing GCP advice to clinical trial teams
- Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.
- Previous experience in supporting Regulatory Authority Inspections preferred
- Previous experience in development and oversight of Quality Management Systems
- Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels
- This position will require up to 25% domestic & international travel
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.
Salary : $132,000 - $165,000
