Associate Director, GCP, RCDQA
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Job Location:
Bedford, NH - USA
Yearly Salary:
$ 160800 - 201000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were 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: Importance of the Role
The Associate Director Research & Clinical Development Quality Assurance (R&CD QA) will provide program-level quality oversight and strategic support across Sareptas Clinical Development and Real-World Evidence portfolio. This role serves as a key Subject Matter Expert in Good Clinical Practice (GCP) compliance ensuring that all clinical trial activities meet FDA regulations ICH guidelines and applicable international standards.As a core member of the Clinical Trial Team the Associate Director will foster collaboration and deliver proactive QA guidance throughout the trial lifecycle. Responsibilities may include integration of acquired clinical programs into existing quality frameworks vendor risk assessment and qualification coordination and execution of investigator site audits internal process audits and inspection readiness activities. This role also drives continuous improvement in quality systems.
The ideal candidate will operate with a high degree of independence demonstrate strong leadership in cross-functional settings and report directly to the Head of R&CD QA GCP/PV.
The Opportunity to Make a Difference
- Provide proactive GxP QA support and guidance to Clinical Trial Teams leveraging analysis and interpretation of GxP regulations to ensure best practices in Clinical and QA operations.
- Lead integration of acquired clinical programs into existing quality frameworks ensuring seamless transition of processes systems and compliance standards following mergers acquisitions or partnerships.
- Partner with teams to resolve compliance issues identified at clinical vendors and investigator sites; assess the impact of deficiencies and recommend corrective actions.
- Assist in the development and implementation of CAPA plans and investigations in response to quality issues audits and inspections.
- Review clinical trial documentation and regulatory submission materials for completeness and compliance with applicable requirements.
- Develop and maintain study-specific audit plans for assigned studies; support audit preparation site selection and execution including coordination of responses.
- Contribute to the implementation and continuous improvement of GxP-compliant procedures and operations to maintain a robust Quality Management System for clinical studies.
- Support inspection readiness activities for sponsors monitors and sites; provide guidance and hands-on support during all GxP inspection activities.
- Coordinate and manage external audit consultants as needed to ensure quality and consistency.
- Perform other related duties and special projects as assigned.
More about You
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 10 years experience in a related industry.
- 8 years experience in a Clinical Quality Assurance role including experience with external and internal audits.
- Demonstrated experience working with clinical trial teams.
- Broad experience in conducting global clinical trials along with a comprehensive understanding of relevant ICH Guidelines FDA regulations and EU requirements.
- Previous experience in supporting regulatory authority inspections preferred.
- Skilled in developing and managing Quality Management Systems.
- Strong interpersonal skills integrity professionalism and ability to build effective relationships with staff across all levels.
- This position may require up to 10% domestic & international travel.
What Now
Were always looking for solution-oriented critical thinkers.
So if youre 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.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.
