Associate Director, Nonclinical Quality

The Associate Director, Nonclinical Quality will be responsible to provide direction to team members around prioritization of deliverables and to work with quality management in conjunction with Genetic Therapies Center of Excellence (GTCOE) and Translational Biology departments. The qualified candidate will serve as a Subject Matter Expert to ensure that activities performed by GTCOE are in compliance with regulatory requirements related to GLP/GCLP.

The Associate Director will be responsible to assure Testing Facility Management (TFM) that Sarepta nonclinical, method qualification and validation, and clinical sample testing studies are conducted in compliance with applicable regulations and Sarepta policies, protocols, methods, and procedures. This position reports to the Director, Nonclinical Quality within Research & Clinical Development Quality Assurance (R&CD QA).

Primary Responsibilities Include:

Lead QAU oversight of assigned areas or programs, including scheduling and conducting internal facility inspections, document reviews (e.g., Policies, SOPs, Methods, and method validation, nonclinical and clinical sample testing protocols), and data and report audits (e.g., for method validation, nonclinical, and clinical sample testing studies).

Report the results of QAU monitoring activities, including observations/findings to management with recommendations for resolution, and confirming that corrective actions have been implemented and documented.

Identify applicable regulatory compliance gaps or risks, notify R&CD QA and Testing Facility Management (TFM) of those gaps or risks, and monitor the development and implementation of risk mitigation measures.

Review any change control activities related to the assigned site(s).

Proactively work with and partnering with site(s) to help establish appropriate regulated (e.g., GLP) environments where needed.

Assist in or lead the management of regulatory authority inspections, and coordinating responses to resolve any inspection finding(s).

Prepare internal QA reports and provide input for cross functional and/or regulatory filings.

Review and approve any quality events associated with the site GMP activities including deviations, investigations, and CAPAs.

Assist in the development of appropriate regulatory training program for staff.

Assist in the development and implementation of standards, policies, and procedures for applicable regulatory compliance.

Report and escalate compliance issues to management, including requests for directed audits.

Participate in quality and compliance improvement initiatives within and outside of Clinical Development / Clinical Operations departments.

Work cross-functionally with other leaders within QA to guide the quality program.

Analyze and distribute metrics data for their assigned areas or programs to R&CD QA Management.

Assist functional leadership in defining organizational goals and strategic plans.

Desired Education and Skills:

BS/BA degree in a scientific discipline from an accredited college or university or equivalent experience.

10+ years of relevant pharmaceutical industry experience, with a minimum of 7 years of QA auditing experience.

Demonstrated understanding of applicable FDA and Global GxP requirements and practices, ability to apply and educate team members and cross-functional partners.

Working knowledge of and ability to interpret and provide developmental phase appropriate guidance on US (FDA) and ex-US (e.g., EMA or MHRA) GLP and applicable GCP regulations, as well as ICH, GCLP and other industry best practices.

Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs).

Experience in planning and conducting internal facility and process inspections for conformance to regulatory and Testing Facility requirements.

Experience with regulatory inspections and inspection readiness.

Experience reviewing Policies, Standard Operating Procedures, and methods to assure compliance with applicable regulatory requirements.

Experience reviewing and auditing study related documentation (e.g., nonclinical, method validation, and clinical testing study protocols, data, and reports).

Strong team player with demonstrated track record of success in a cross functional team and fast moving environment.

Excellent organizational, computing, and oral/written communication skills.

Ability to influence and negotiate effective solutions.

Strong critical thinking and decision-making skills.

Ability to travel up to 25%.

#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 $148,400 - $185,500 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.

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