Quality Inspection Readiness Director
GSK, King Of Prussia, PA, United States
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.
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
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
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
Basic Qualifications
Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Preferred Qualifications
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
Travel & Hybrid This role is hybrid, but requires the candidate to be close to a GSK site. This role will require travel up to 50%.
Compensation 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!
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $162,525 to $270,875.
Benefits 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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
EEO Statement 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.
Important Notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com
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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.
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
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
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
Basic Qualifications
Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Preferred Qualifications
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
Travel & Hybrid This role is hybrid, but requires the candidate to be close to a GSK site. This role will require travel up to 50%.
Compensation 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!
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $162,525 to $270,875.
Benefits 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.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
EEO Statement 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.
Important Notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com
#J-18808-Ljbffr