Quality Inspection Readiness Director

GSK • Rockville, MD

3d • Hybrid

About The Position

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.
The primary purpose of the Quality Inspection Readiness Director is to assist sites to be inspection ready every day via coaching, training and educating and for sites inspected by key regulators (FDA, MHRA, EMA (outside of Europe), HPRA and China) by carrying out site and product assessments This role will be responsible for working with sites to apply processes associated with being inspection ready everyday and to assure that local processes are implemented at the sites that are highly regulated. You will participate (where appropriate) or use information shared by GSK attendees at external/internal fora to ensure up-to-date knowledge on GMP compliance is maintained and bring information into GSK. You will provide advice on current industry trends and support regulatory compliance for the introduction of new technologies, aligned with the existing regulatory and cGMP framework, as requested

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Requirements

• Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.

Nice To Haves

• 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
• Proficiency & experience in identifying Regulatory Inspection Risks
• Demonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions
• Broad based familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturing
• Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP compliance
• Knowledge of risk management principles and application
• Understanding and experience of corporate governance processes
• Serious Incident management with demonstrated ability to resolve quality issues
• Demonstrated improvement in processes associated with being inspection ready

Responsibilities

• 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)
• Pre-Inspection - Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approach
• 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
• During 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 response
• 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
• Support site capability building through training and coaching of site SMEs in preparation for GMP regulatory Inspections
• 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.
• 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
• Provide interpretation and consultation to project teams on (new/updated) regulations, guidelines, compliance status and policies and procedures
• Be the point of contact with sites being assessed for inspection readiness
• Propose updates to Global QMS Documents and/or local site SOPs based upon identified compliance gaps
• Assist in training and coaching of guest assessors
• Expand knowledge through proactive knowledge sharing and collaboration
• Promote excellence and continuous improvement associated with inspection readiness, best practice and processes
• Support site capability building through training and coaching of site SMEs in preparation for Inspections
• Work with the QMS team on QMS policies & global processes associated with Inspection Readiness team
• Participation in IR CoP/Compliance Forum
• Share learning from significant Regulatory Inspections across GSC as necessary
• Develop and maintain tools to support inspection readiness process
• Ensure suitable metrics (KPI’s) are in place and are available to support decision-making within GSK

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees