Quality Systems & Data Associate Director
About the role
At GSK we manufacture and supply reliable, high‑quality medicines and vaccines. The Associate Director, Quality Systems & Data provides leadership to a team of quality professionals overseeing data integrity and governance, training compliance, Quality Management System (QMS) deployment, and quality oversight of the Digital Strategy (SMART Manufacturing). The role also defines and drives the site Quality Improvement Plan, Quality Culture, and supports the site Quality Leadership Team with data analytics and GPS. This position reports to the Site Quality Director and is a member of the site Quality Leadership Team.
Responsibilities
- Provide leadership and strategy for the site data integrity & governance program, working closely with central and site teams.
- Create and drive the Quality digital strategy (SMART manufacturing) in collaboration with site and central functions.
- Manage updates to site quality systems including VQMS and MERP through appropriate change‑management procedures.
- Lead the GSK Quality Management System deployment through effective execution.
- Collaborate with cross‑functional teams to ensure alignment and integration of quality systems and processes.
- Ensure comprehensive training compliance for all relevant personnel, maintaining up‑to‑date training records and facilitating necessary training programs.
- Develop, implement, and monitor the Quality Improvement Plan, driving continuous‑improvement initiatives and fostering a Quality Culture at the site.
- Maintain a thorough and current working knowledge of compliance requirements, FDA regulatory developments, industry trends, and ethical pharmaceutical practices; interpret regulatory quality and compliance requirements and integrate them into site quality systems.
- Provide leadership and direction to a team of 5‑15 quality professionals, fostering a culture of quality and compliance.
- Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.
Basic Qualifications
- B.A. / B.S. degree in a science such as Science, Engineering, or pharmaceutical quality.
- 10+ years of industrial experience in a commercial pharmaceutical manufacturing facility.
Preferred Qualifications
- In‑depth experience in quality systems, including validation, compliance, and operating a high‑volume, rapid‑turnaround environment.
- Strong technical understanding of industry and scientific practices related to the business.
- Prior experience leading significant improvement programs.
- Fully versed in GMPs, NIH Guidelines, FDA and other regulatory agency compliance requirements for validation, operations, analytical, and stability functions.
- Strong interpersonal and leadership skills; solid team player within a team‑based organization.
- Excellent verbal and written communication skills.
- Ability to interact with peers, subordinates, and senior personnel across multidisciplinary functions (engineering, facility operations, validation, supply chain, production, QC, finance, EHS).
- Ability to prioritize, decide appropriate courses of action, and effectively implement decisions.
Skills
- Data Integrity
- Data Quality
- Digital Fluency
- GxP Regulations
- Influencing Without Authority
- Lean Management
- Problem Solving
- Project Management
- Quality Assurance (QA)
- Quality Metrics
- Risk Awareness
- Technical Writing
- Technology Management
Benefits
Visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers U.S. employees.
Why GSK?
GSK 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, delivering innovative specialty medicines and vaccines across respiratory, immunology & inflammation, oncology, HIV, and infectious diseases. Our culture is ambitious for patients, accountable for impact, and committed to doing the right thing, creating an environment where our people can thrive.