We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines 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. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible.
Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Are you ready to make a meaningful impact in ensuring regulatory compliance and inspection readiness across a global organization? As a Quality Inspection Readiness Director, you will play a key role in supporting sites to meet regulatory standards and maintain inspection readiness every day. You will collaborate with cross-functional teams, provide expert guidance, and drive continuous improvement in compliance processes. This is an opportunity to grow your career while contributing to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.
1. Support GSK sites/related functions that are inspected by key regulators (FDA, MHRA, EMA (outside of Europe), HPRA and China) to be inspection ready through Inspection Readiness Pre, During and Post Inspection activities (including PAI inspection readiness)
2. Pre-Inspection - Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approach
3. Preparation of clear and objective assessment reports that ensure that senior management is communicated any inspection readiness risks and that appropriate corrective action plans are implemented which are associated with those risks
4. During Inspection – Provide appropriate support for all key Regulatory Inspections (e.g. SME coaching, Control Room and Inspection Room Support)
5. Post Inspection – Review the regulatory response as part of the central review team process, perform Global Assessments and participate in After Action Reviews. If necessary, initiate Muti-Site Commitment actions if there is a wider GSK impact by the regulatory response
6. Serve as a business partner to enhance GSK’s risk management capabilities and actively identify and share good practices and improvement opportunities in the appropriate format
7. Support site capability building through training and coaching of site SMEs in preparation for GMP regulatory Inspections
8. Review and check CAPA for key regulatory inspections and engagements before the next site inspection by a key regulator to ensure they have been closed out effectively.
9. Attend internal forums (as required) as GMP/GDP expert, providing recommendations to provide recommendations for continued compliance with regulations, in support of the simplification and advancement of the use of new technology in the current processes
10. Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures
In addition:
11. Be the point of contact with sites being assessed for inspection readiness
12. Propose updates to Global QMS Documents and/or local site SOPs based upon identified compliance gaps
13. Assist in training and coaching of guest assessors
14. Expand knowledge through proactive knowledge sharing and collaboration
15. Promote excellence and continuous improvement associated with inspection readiness, best practice and processes
16. Support site capability building through training and coaching of site SMEs in preparation for Inspections
17. Work with the QMS team on QMS policies & global processes associated with Inspection Readiness team
18. Participation in IR CoP/Compliance Forum
19. Share learning from significant Regulatory Inspections across GSC as necessary
20. Develop and maintain tools to support inspection readiness process
21. Ensure suitable metrics (KPI’s) are in place and are available to support decision-making within GSK
Basic Qualifications
22. Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Preferred Qualifications
23. Good knowledge of world-wide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile
24. Proficiency & experience in identifying Regulatory Inspection Risks
25. Demonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions
26. Broad based familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturing
27. Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP compliance
28. Knowledge of risk management principles and application
29. Understanding and experience of corporate governance processes
30. Serious Incident management with demonstrated ability to resolve quality issues
31. Demonstrated improvement in processes associated with being inspection ready
This role is hybrid, but requires the candidate to be close to a GSK site. This role will require travel up to 50%.
Join us in this impactful role and help ensure GSK’s commitment to quality and compliance. Apply today to be part of a team that’s making a difference in global health!
The US annual base salary for new hires in this position ranges from $151,800 to $253,000 The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Please visit to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that 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 (including family medical history), military service or any basis prohibited under federal, state or local law.
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