Director, Operational Quality
Listed on 2026-03-08
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Quality Assurance - QA/QC
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Healthcare
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Feb 24 2026
We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people.
Position SummaryAre you looking for an opportunity to drive the development, deployment, and sustainability of the quality management system for the manufacture and supply of products from a contract network? If so, this is the role for you. As the Third‑Party Quality Director, you will lead the quality activities for third‑party contract operations of both Large and Small Molecule, including new business developments, while supporting the performance of contract manufacturing companies over which GSK does not have direct control.
Responsibilities- Provide leadership for securing new products from business partners in GSK and outside GSK
- Manage development and performance objectives while providing coaching, mentoring, and feedback on a regular basis to a team of Quality professionals
- Establish clear accountabilities regarding product quality, employee safety, cGMP compliance, OSHA compliance, and consistently achieving production schedules to meet market demand
- Guide, support, train and assess third‑party sites in regulatory inspections, including response writing
- Support the efforts to positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly collated, analyzed, and distributed for incorporation in local action plans
- Lead site GMP compliance activities including self‑inspection, internal audit, compliance metrics, Quality Management System implementation, Quality Regulatory Intelligence, Quality Risk Model, DEA compliance, and CAPA verification
- Embed industry manufacturing tools and techniques to identify, manage, and expand problems and develop solutions
- Mobilise and co‑ordinate appropriate resources to address any significant product quality or regulatory incident
- Achieve objectives and work with a direct and indirect multi‑functional team of Commercial, Business Development, Regulatory, Technical and Supply within the region and the wider GSK global team
- Influence, build good relationships with key individuals, internally and externally, with pressure and recourse to contractual requirements
- Develop the capability of staff, including the understanding of regulatory changes
- Promote early visibility of regulatory issues providing appropriate GSK response and position
- Foster teamwork and promote GSK values, behaviours, and strategies
- Bachelor’s Degree
- 7+ years of pharmaceutical industry experience
- Experience in at least one of the areas of Quality Assurance/Operations, Production, or Engineering
- Project management experience
- Team leadership experience
- Master’s degree
- Knowledge of worldwide good manufacturing practices, regulatory requirements, and standards
- Knowledge of the pharmaceutical industry’s current best practice in manufacturing and analytical technologies, engineering practices, validation and GMP compliance
- Experience with Contract Manufacturers
- Demonstrate initiative analytical problem‑solving skills
- Ability to use and interpret data to drive decision making at both a tactical and strategic level
- Ability to be flexible, adaptable, and a strong team player
Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program offered to US employees.
About GSKGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade. Our therapeutic focus includes respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We welcome people who thrive on ambition for patients, accountability for impact, and doing the right thing.
Adjustments& Inclusion
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, please contact where you can also request a call. If your inquiry does not relate to adjustments, we will not be able to support you through these channels.
Equal Opportunity Employer StatementGSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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