Quality Inspection Readiness Director
GSK LLP, Hamilton, MT, United States
Quality Inspection Readiness Director
Position can be located at any site in the US, UK, or Europe.
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.
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.
The primary purpose of the Quality Inspection Readiness Director is to assist sites to be inspection ready every day through coaching, training and education, and for sites inspected by key regulators (FDA, MHRA, EMA, HPRA and China) by carrying out site and product assessments. This role will be responsible for working with sites to implement processes associated with being inspection ready every day and to assure that local processes are implemented at highly regulated sites. You will participate in or use information shared by GSK attendees at external/internal forums 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.
Responsibilities
Support GSK sites/related functions that are inspected by key regulators (FDA, MHRA, EMA, 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.
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 multi‑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 a GMP/GDP expert, providing 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.
Additional Responsibilities
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.
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 (KPIs) are in place and are available to support decision‑making within GSK.
Basic Qualifications
Bachelor's degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Preferred Qualifications
Good knowledge of worldwide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and quality management systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and sterile products.
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 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.
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.
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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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.
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.
The primary purpose of the Quality Inspection Readiness Director is to assist sites to be inspection ready every day through coaching, training and education, and for sites inspected by key regulators (FDA, MHRA, EMA, HPRA and China) by carrying out site and product assessments. This role will be responsible for working with sites to implement processes associated with being inspection ready every day and to assure that local processes are implemented at highly regulated sites. You will participate in or use information shared by GSK attendees at external/internal forums 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.
Responsibilities
Support GSK sites/related functions that are inspected by key regulators (FDA, MHRA, EMA, 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.
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 multi‑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 a GMP/GDP expert, providing 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.
Additional Responsibilities
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.
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 (KPIs) are in place and are available to support decision‑making within GSK.
Basic Qualifications
Bachelor's degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Preferred Qualifications
Good knowledge of worldwide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and quality management systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, and sterile products.
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 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.
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.
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.
#J-18808-Ljbffr