Senior Manager, Corporate Quality – R&D Audits

·         Bachelor’s degree in Life Sciences with 8+ years in pharmaceutical or biotech drug development. Advanced degree preferred.

·         Minimum 5 years of experience in GPV a GLP/GCLP, including both external and internal auditing.

·         Extensive experience with OECD Principles on GLP, GPV, ICH E6 GCP Guideline, FDA Regulations and EU Requirements.

·         Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross-functional personnel at all levels.

·         Must be able to travel domestically and/or internationally 20% of the time.

·       Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors. Develop audit plans, conduct quality audits, prepare audit reports, and communicate and escalate findings, including compliance risk.

·       Conduct Quality Audits associated with qualification of new vendors.

·       Conduct for cause audits of external vendors as requested by management.

·       Review and evaluate vendors audit response against current industry standards and guidelines to ensure sufficient controls are in place by the supplier to meet quality requirements.

·       Serve as a QA point of contact for vendor-related audits, performance oversight, and compliance decision-making.

·       Assist in the maintenance of the annual external audit schedules as requested by management.

·       Provie support during GXP health authority inspections

·       Revise and create GxP quality documentation, including SOPs, policies, templates, and work instructions.

·       Manage auditing files, records, reports, licenses and certificates associated with the approved vendor program.

·       Assumes additional duties and responsibilities as assigned.