Senior Manager, Research & Clinical Development QA Audit Management at Sarepta Therapeutics in Cambridge, Massachusetts

Job Description:

Reporting to the Director, Research & Clinical Development Quality Assurance, the Sr. 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.

Primary position responsibilities include:

• Plans, prepares and conducts GLP/GCP audits of clinical investigators, nonclinical and clinical vendors and systems.


• Assists 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


• 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 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

Requirements:

• Bachelor's degree in the Life Sciences with 8+ years in pharmaceutical or biotech drug development. Advanced degree preferred.


• Minimum 5 years of experience in GLP/GCP/GVP, including both external and internal auditing.


• 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


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  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.