Product Quality Lead

The Product Quality Lead provides cross‑functional quality leadership and supports program deliverables for assigned products and associated on‑going life‑cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as the main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross‑functional teams supporting the product lifecycle.

The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products. This is a hybrid role that requires on‑site presence in one of our offices (Morrisville, NC or San Diego, CA).

• Ensure end‑to‑end compliance for product manufacturing and life cycle management, from clinical phase to the termination of the commercialization of the product (as applicable).
• Provide quality inputs in submission dossiers.
• Implement and maintain quality risk assessment and key performance indicators (KPIs).
• Lead complex changes.
• Coordinate product QA activities across markets (e.g., launch).
• Provide guidance on product quality aspects and support site transfers.
• Participate in audits and inspections.
• Design SOPs and contribute to operational development.
• Contribute to input in the quality aspect of due diligence processes.
• Advise and lead complex quality issues and influence global solutions to ensure continuous drug supply to patients.
• Collaborate closely with the rest of the quality functions to ensure product quality requirements, issues, or solutions are promptly communicated at all appropriate levels.
• Support recall.
• Responsible for coordination, issuing and approval of the APQR.
• Contribute to developing and streamlining own operations.
• Lead and coordinate the quality aspect for integration of new acquisitions.
• Cooperate with team members and contribute to a positive work environment.