Global Product Quality Strategy Lead

GlaxoSmithKline; Marietta (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

GlaxoSmithKline is seeking a Product Quality Strategy Director to lead end-to-end quality strategy for pivotal assets through launch and lifecycle management. This role acts as the One Quality Voice across CMC, Regulatory, R&D, and manufacturing, ensuring patient safety and compliance.

The position requires strong leadership in GMP, lifecycle management, and regulatory submissions, with a track record of matrix leadership and governance participation.

Qualifications

• Bachelor's degree required.
• 10+ years of pharmaceutical-industry experience across Quality and/or Technical functions.
• Experience in GMP.
• Experience with product lifecycle management.
• Experience with product quality risk management and new product introduction.
• Experience with regulatory submissions and inspection readiness.
• Matrix leadership experience.
• Governance participation experience.

Responsibilities

• Develop, maintain, and integrate end-to-end Product Quality Strategy for assigned assets from pivotal readiness through launch and lifecycle management, embedding Quality, Regulatory, and supply considerations in asset strategy.
• Lead the Product Quality Team and influence matrix stakeholders across Quality, R&D, MSAT, Manufacturing, Regulatory, and external partners to align plans and delivery.
• Represent Quality as the One Quality Voice at senior governance forums, providing objective risk-based recommendations and escalating issues as needed.
• Provide Quality leadership for pivotal, filing, launch, inspection, and post-approval readiness, including strategy inputs for control and regulatory submissions.
• Be accountable for Product Quality elements within cross-functional matrix teams and for review/approval of deliverables and milestone readiness.

Skills

Leadership

Cross-functional

GxP Knowledge

Regulatory awareness

Problem solving

Education

Bachelor's degree

Job description

GlaxoSmithKline is seeking a Product Quality Strategy Director to lead end-to-end quality strategy for pivotal assets through launch and lifecycle management. This role acts as the One Quality Voice across CMC, Regulatory, R&D, and manufacturing, ensuring patient safety and compliance.

The position requires strong leadership in GMP, lifecycle management, and regulatory submissions, with a track record of matrix leadership and governance participation.