Quality Inspection Readiness Director
GlaxoSmithKline, Collegeville, PA, United States
Job Overview
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.
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.
Prepare clear and objective assessment reports that ensure 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 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 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.
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 and global processes associated with Inspection Readiness team.
Participate 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.
Qualifications
Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Good knowledge of worldwide cGMPs and regulatory requirements; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile.
Proficiency and 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.
Location & Compensation Location: GSK site (close to a GSK site). The role is hybrid and requires travel up to 50%.
Salary: For US positions (Cambridge MA, Waltham MA, Rockville MD, San Francisco CA) annual base salary ranges from $162,525 to $270,875. Includes an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include health care, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
About GSK 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.
We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.
Our culture emphasizes ambition for patients, accountability and doing the right thing.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
Contact & Equality 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.
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, 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.
Transparency For US licensed healthcare professionals, GSK may be required to capture and report expenses incurred on your behalf, in the event you are afforded an interview for employment. For more information, please visit the Centers for Medicare & Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.
#J-18808-Ljbffr
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.
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.
Prepare clear and objective assessment reports that ensure 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 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 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.
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 and global processes associated with Inspection Readiness team.
Participate 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.
Qualifications
Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
Good knowledge of worldwide cGMPs and regulatory requirements; experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile.
Proficiency and 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.
Location & Compensation Location: GSK site (close to a GSK site). The role is hybrid and requires travel up to 50%.
Salary: For US positions (Cambridge MA, Waltham MA, Rockville MD, San Francisco CA) annual base salary ranges from $162,525 to $270,875. Includes an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include health care, retirement, paid holidays, vacation, paid caregiver/parental and medical leave.
About GSK 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.
We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.
Our culture emphasizes ambition for patients, accountability and doing the right thing.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
Contact & Equality 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.
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, 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.
Transparency For US licensed healthcare professionals, GSK may be required to capture and report expenses incurred on your behalf, in the event you are afforded an interview for employment. For more information, please visit the Centers for Medicare & Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.
#J-18808-Ljbffr