Senior Manager, Corporate Quality – R&D Audits

Sarepta Therapeutics•Bedford, MA

40d•$136,000 - $170,000•Hybrid

About The Position

The Sr. Manager, Corporate Quality Audits, provides GxP oversight for the vendor management and audit program, with primary responsibility for GPV and GLP/GCLP vendor audits. The role ensures compliance with FDA, ICH, OECD, and other global requirements, supports the integration of acquired programs, and drives continuous improvement of quality systems.

Requirements

Candidates must be authorized to work in the U.S.

Nice To Haves

Solution-oriented, critical thinkers.
Comfortable with ambiguity and candor.
Relish challenging yourself.
Place kindness and integrity at the forefront of how you approach your peers and work.

Responsibilities

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.
Provide 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.