Senior Manager, Corporate Quality – R&D Audits

Regulatory Toolkit; Bedford (MA); Hybrid; USD 136,000 - 170,000; Full time

Benefits offered by this job

Physical and Emotional Wellness

Financial Wellness

Support for Caregivers

Job summary

Sarepta Therapeutics is seeking a Senior Manager, Corporate Quality Audits to lead GPV and GLP/GCLP vendor audits and ensure compliance with FDA, ICH, OECD, and global requirements.

The role is hybrid, based on-site at Sarepta facilities in the United States, with domestic/international travel up to 20%. You will drive audit plans, reporting, and continuous quality improvements while supporting acquisitions and inspections.

Qualifications

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

Responsibilities

• Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors. Develop audit plans, conduct quality audits, prepare audit reports, and communicate and elevate 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.

Skills

GxP Audits

External/Internal Auditing

Vendor Management

Regulatory Compliance

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

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 diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're 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: https://www.sarepta.com/join-us

The Importance of the Role

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.

The Opportunity to Make a Difference

Primary responsibilities include:

• Conduct GPV and GLP/GCLP external audits of Sarepta approved vendors. Develop audit plans, conduct quality audits, prepare audit reports, and communicate and elevate 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.

More about You

Education and Skills Requirements:

• 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.

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 $136,000 - $170,000 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.

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.