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Associate Director Research
3 months ago
The Associate Director, R&CD Quality Assurance will be responsible for the delivery and execution of the Sarepta internal and external audit program, risk based audit plan development, and the conduct of GLP/GCP/GVP audits. The Associate Director will participate in vendor risk assessment and vendor qualification, GxP audit consultation management, and the development of performance, quality and risk metrics. This position will also participate in inspection readiness activities and audits, as appropriate. This position will require up to 20% travel, domestic and international and report to the Director, Research & Clinical Development Quality Assurance (R&CD QA).
Primary position responsibilities include:
- Full management of Vendor Audit program. Liaison and coordination of audits, hosting of regular meetings with Procurement leaders at comparable Associate Director/ Director level.
- Leadership of audit CAPA resolution with external vendors including Tier 1 CROs. Engaging with senior leaders within Sarepta and in vendor organizations to agree appropriate action plans to ensure compliance across Sarepta programs.
- Point of contact for Investigator Site Audits.
- Training and oversight of junior staff:
- Cross training junior staff on vendor questionnaire process.
- Leading cross training of GxP staff from other QA teams on GCP audit processes
- Input into development of the expanded internal audit program and support of execution.
- Point of contact for external audit organizations.
- Participate in the development of internal and external GLC/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities
- Oversight of GLP/GCP/GVP new vendor risk assessment, initial qualification and existing vendor requalification
- Maintenance of Nonclinical and Clinical Approved Vendor List (AVL) for Nonclinical Development, Clinical Development Operations, Medical Affairs, and Global Pharmacovigilance
- Maintenance of Nonclinical and Clinical Audit Program, Process, relevant SOPs
- Lead role in the ensuring consistency and standardization in audit execution and reporting, auditor qualification, trial risk assessments, and study audit plans
- Assist in the development and maintenance of GxP audit management documentation including policies, SOPs, Work Instructions, and guidelines.
- Collaborate with Clinical Trial Team members to assess ongoing audit needs and provide GxP guidance to functional teams, and execute directed audits, where required.
- Participate in inspection readiness and preparedness activities (i.e., sponsor monitor, sites, etc.) and provide guidance and support for all GxP inspection activities
- Lead role in the support of internal and external regulatory inspections and Inspection Readiness activities
- Management and oversight of external Audit Consultants, as appropriate
- Oversight and the maintenance of clinical site/vendor audit documentation archive
- Contribute to site and vendor audit observation database and generation of audit trends and metrics
**Requirements**:
- Bachelor’s degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred.
- Minimum 7 years of experience in GLP/GCP/GVP, including both external and internal auditing.
- Demonstrated experience working with 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 facilitating and/or supporting Regulatory Authority Inspections
- 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
LI-Hybrid
This position is hybrid, 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 $156,000 - $195,000 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.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
