Associate Director, QA Clinical Operations DP

The Associate Director of QA Clinical Operations DP will manage a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture, Drug Products (DP) for clinical products. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to ensure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. He/she will be responsible for the coordination of the activities of multiple areas in departments with responsibility for results. Objectives with significant impact on the department and organization.

Primary Responsibilities Include:

• Generally provides direction to team members around prioritization of deliverables related to lot release
• Responsible for resource allocation and personnel development
• Responsible for triage & distribution of internal and external information to team members
• Cross-functionally partners with leaders for direction of program
• Responsible for analysis and distribution of metrics data
• Solution focused; Accountable for problem-solving within team
• Monitors metrics of staff and tracking against performance expectations
• Supports investigation, deviation activities and CAPAs and provides general quality assurance support for the overall Quality System at Sarepta.
• Responsible for multiple direct reports
• Typically assists executives and/or senior directors in defining organizational goals and strategic plans
• Establishes final decisions on administrative or operational matters and ensures effective achievement of objectives
• Manages activities of two or more sections or departments. Exercises supervision in terms of costs, methods, and staffing. In some instances, this manager may have subordinate supervisors 
• Typically works on complex issues where analysis of situations or data requires an in-depth knowledge of the company
• Works on objectives that have critical impact on functional area and the organization
• Travel to Contract Manufacturing Organizations for periodic meetings is required

Desired Education and Skills:

• BA/BS degree in a related field, 10 + years related experience
• Demonstrated understanding FDA/ICH GMP/GCP/GLP/GDP requirements and practices, ability to apply and educate team members and cross-functional partners
• Electronic Quality Management Systems (eQMS) knowledge
• Must have extensive technical knowledge of pharmaceutical manufacturing and laboratory operations
• Working knowledge of US & ex-US regulations
• Ability to apply phase-appropriate guidance to development
• Proficient in Microsoft suite

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.

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.