The Opportunity:

The Director, GMP QA Operations will serve as the GMP Quality lead for assigned clinical and commercial products and programs. This position will provide Quality oversight across the external manufacturing and supply network, including Drug Substance (DS), Drug Product Intermediates (DPI), Drug Product (DP), Finished Product (FP), and Packaged Product.

The Director will be responsible for GMP material oversight, external manufacturer and supplier oversight, and batch disposition activities for assigned products. The role will partner closely with internal cross-functional teams and external manufacturing partners to ensure product quality, GMP compliance, inspection readiness, and timely supply.

This position reports to the Executive Director, GMP QA.

Responsibilities:

• Serve as the GMP QA Operations lead for assigned products and programs, providing Quality leadership, strategic direction, and oversight of GMP operational activities.

• Provide end-to-end QA oversight of GMP manufacturing, testing, packaging, and supply activities across Drug Substance, Drug Product Intermediates, Drug Product, Finished Product, and Packaged Product.

• Provide QA oversight of GMP materials, CMOs, CDMOs, testing laboratories, packaging sites, suppliers, and other external GMP partners supporting assigned products.

• Lead Quality interactions with external partners to ensure alignment on quality expectations, priorities, risks, and batch release timelines.

• Review batch records, testing documentation, certificates, and other GMP documentation supporting batch disposition. Perform or approve batch disposition in accordance with applicable procedures, regulatory requirements, and product specifications.

• Review and approve deviations, investigations, OOS/OOT results, CAPAs, change controls, and other quality events. Ensure issues impacting batch disposition are appropriately evaluated and resolved before release.

• Assess product quality and compliance risks. Drive timely resolution of operational Quality issues and escalate significant risks that may impact product quality, compliance, or supply.

• Partner with Supply Chain, Manufacturing, Technical Operations, Analytical, Regulatory, and other functions. Represent GMP QA Operations on product and cross-functional teams for assigned products.

• Provide GMP QA Operations support for product launches, technology transfers, manufacturing site changes, and post-approval lifecycle activities.

• Support regulatory submissions, health authority inquiries, inspection readiness, and regulatory inspections related to assigned products and external manufacturing operations.

• Support qualification and ongoing Quality oversight of GMP suppliers and external manufacturing partners. Review quality metrics and identify adverse trends, recurring issues, and emerging compliance risks.

• Promote consistent GMP QA Operations practices and Quality standards across products and external manufacturing partners.

• Provide leadership and direction to GMP QA Operations team members supporting assigned products. Establish priorities and ensure effective execution of Quality activities.

• Lead, mentor, and develop team members. Provide technical guidance and coaching on complex GMP Quality issues and risk-based decision making. Foster collaboration, accountability, and timely escalation of significant issues.

Required Skills, Experience and Education:

• Bachelor's degree in a scientific or technical discipline is required.

• A minimum of 12+ years of experience in GMP Quality in the pharmaceutical industry is required with focus on small molecule manufacturing, with 5 years managerial experience in GMP area.

• Significant experience supporting clinical, late-stage and commercial pharmaceutical manufacturing.

• Strong experience with batch record review, batch release, and product disposition.

• Experience providing Quality oversight of CMOs, CDMOs, testing laboratories, packaging sites, and suppliers.

• Experience with Drug Substance and Drug Product manufacturing. Experience with oral solid dosage forms is preferred.

• Strong knowledge of GMP requirements applicable to commercial manufacturing and product release.

• Experience with deviations, investigations, OOS/OOT results, CAPAs, change controls, and other GMP quality systems.

• Experience supporting regulatory inspections and inspection readiness for FDA and other global health authorities.

• Experience supporting regulatory filings and post-approval lifecycle activities.

• Ability to independently assess complex product quality and compliance issues and make risk-based Quality decisions.

• Strong external partner management and cross-functional leadership skills.

• Ability to manage multiple products, priorities, and manufacturing activities in a fast-paced environment.

• Excellent written and verbal communication skills.

Preferred Skills:

• Experience with commercial batch disposition across DS, DP, and packaged product.

• Experience supporting commercial product launches and post-approval lifecycle management.

• Experience managing Quality activities across multiple CMOs and external manufacturing partners.

• Experience with oral solid dosage forms and commercial packaging operations.

• Experience supporting global commercial supply.

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