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.ResponsibilitiesSupport 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)Pre-Inspection - Prepare for, conduct and manage Inspection Readiness support activities / Assessments of sites utilizing a risk-based approachPreparation 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 risksDuring Inspection – Provide appropriate support for all key Regulatory Inspections (e.g. SME coaching, Control Room and Inspection Room Support)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 responseServe as a business partner to enhance GSK’s risk management capabilities and actively identify and share good practices and improvement opportunities in the appropriate formatSupport site capability building through training and coaching of site SMEs in preparation for GMP regulatory InspectionsReview 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.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 processesProvide interpretation and consultation to project teams on (new / updated) regulations, guidelines, compliance status and policies and proceduresAdditional ResponsibilitiesBe the point of contact with sites being assessed for inspection readinessPropose updates to Global QMS Documents and / or local site SOPs based upon identified compliance gapsAssist in training and coaching of guest assessorsExpand knowledge through proactive knowledge sharing and collaborationPromote excellence and continuous improvement associated with inspection readiness, best practice and processesSupport site capability building through training and coaching of site SMEs in preparation for InspectionsWork with the QMS team on QMS policies & global processes associated with Inspection Readiness teamParticipation in IR CoP / Compliance ForumShare learning from significant Regulatory Inspections across GSC as necessaryDevelop and maintain tools to support inspection readiness processEnsure suitable metrics (KPI’s) are in place and are available to support decision-making within GSKBasic QualificationsBachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.Preferred QualificationsGood knowledge of world-wide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterileProficiency & experience in identifying Regulatory Inspection RisksDemonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissionsBroad based familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturingGood knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP complianceKnowledge of risk management principles and applicationUnderstanding and experience of corporate governance processesSerious Incident management with demonstrated ability to resolve quality issuesDemonstrated improvement in processes associated with being inspection readyThis role is hybrid, but requires the candidate to be close to a GSK site. This role will require travel up to 50%.BenefitsThe 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.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!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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