Product Quality Lead

Description:

GSK is seeking a Product Quality, Strategy Lead for their Ware, Hertfordshire location. The role is responsible for overseeing the quality management of products from the commit phase through phase III to commercial launch and product lifecycle. The individual will ensure compliance with appropriate standards, oversee risk detection, and manage quality changes, deviations, and CAPAs in compliance with cGMP standards.

Key Responsibilities:

• Oversee product quality from Phase III through to commercial launch and post-launch product lifecycle.

• Ensure compliance with cGMP standards for changes, deviations, and CAPA management.

• Manage product quality risks and implement mitigation actions.

• Review dossiers and files submitted to health authorities and approve regulatory submissions.

• Support pre-approval inspection readiness.

• Provide functional expertise to quality functional areas, including external quality, lot release, and more.

• Communicate and escalate issues to line managers and resolve them through appropriate governance forums.

• Manage post-approval changes and provide oversight for viral safety, sterility assurance, and device controls for aligned products.

Why You?

Basic Qualifications:

• Degree or equivalent in life sciences or a related sector.

• Experience in the pharmaceutical industry, understanding of GMP, and clinical manufacture and release standards.

• Experience in quality assurance and quality control in R&D or commercial environments is desirable.

• Demonstrated ability to work across various functions.

• Clear communication skills, both verbal and written.

Why GSK?
GSK is a global biopharma company focused on vaccines, specialty and general medicines. The company strives to unite science, technology, and talent to fight disease and improve global health. GSK is committed to creating an inclusive, diverse workplace where employees feel inspired and valued.