Product Lifecycle Compliance Team Leader

We need to output HTML fragment with sections: headings

for sections present with real content. Must not repeat job title. Must not include Job ID etc. Must remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. Must preserve substantive info. We need to parse the posting: It includes Business Introduction, Position Summary, Responsibilities, Why You? (maybe includes Work arrangement, Basic Qualification, Preferred Qualification), How To Apply (should be removed), About The Zebulon Site (maybe keep as part of description?), Skills, Benefits (link to GSK US Benefits Summary but no details), Why GSK? (maybe keep?), plus some other sections like Work arrangement, Basic Qualification, Preferred Qualification. We need to decide which sections to include based on real specific content. We must include sections only when posting has real, specific content for it. Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We can use other headings? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely we should use those exact headings if applicable. But we can also use other headings? It says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Probably they expect we use those headings when appropriate. However we can also have other headings like "Business Introduction" maybe not needed. The instruction: "use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It suggests those are examples; we can use other headings if needed but likely they want those standard headings. We'll map content to these sections. We need to decide what goes where. - About the role: Could be Position Summary + Business Introduction? Probably "About the role" corresponds to Position Summary and maybe Business Introduction. We'll put Position Summary content there. - Responsibilities: list of duties. - Requirements: maybe Basic Qualification. - Qualifications: maybe Preferred Qualification. - Skills: list of skills. - Benefits: we have link to GSK US Benefits Summary but no details; we should not create Benefits section unless posting actually states them. It only says "Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees." That's not specific benefits; it's a referral. According to rule: never create Pay/Schedule/Benefits sections unless the posting actually states them. Since it doesn't state specific benefits, we should omit Benefits section. - Pay: not stated; omit. - Schedule: Work arrangement is hybrid; that's schedule info. So we can include Schedule section with that content. We also have "Why You?" which includes Work arrangement, Basic Qualification, Preferred Qualification. We'll split. We also have "About The Zebulon Site" which is descriptive; could be part of About the role or maybe separate but not a standard heading. Could be included in About the role. We also have "Skills" list. We also have "Why GSK?" which is fluff; maybe we can omit as it's boilerplate? It's somewhat generic but maybe considered boilerplate? It's about company mission; could be considered boilerplate but it's specific to GSK. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. "Why GSK?" might be considered boilerplate but it's not legal; it's marketing. Might be okay to keep? However they said prefer a few substantive sections over many thin ones. Might be better to omit "Why GSK?" as it's not directly about the role. But we could include as part of About the role? Not sure. We also have "How To Apply" which must be removed. We also have "Important notice to Employment businesses/ Agencies" etc - legal boilerplate; remove. We also have "If you require an accommodation..." etc - remove. We also have "GSK is an Equal Opportunity Employer." - remove. We also have "Please note that if you are a US Licensed Healthcare Professional..." - remove. Thus we keep: Business Introduction (maybe as part of About the role), Position Summary, Responsibilities, Work arrangement (Schedule), Basic Qualification (Requirements), Preferred Qualification (Qualifications), Skills, About The Zebulon Site (maybe part of About the role), maybe we can keep as a separate section "About the site" but not in list; but we could incorporate. We need to output only HTML fragment, no markdown fences. We'll structure:

About the role

Business Introduction paragraph(s) + Position Summary paragraph(s) maybe combined.

Responsibilities

• ... each responsibility.

Schedule

Work arrangement: hybrid, expected to work on-site regularly, with flexibility for remote work as agreed with your manager.

Requirements

• 8+ years experience in a GMP-regulated pharmaceutical environment, with 5+ years of relevant experience in a quality or compliance role.
• Experience leading people and cross-functional activities.
• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or other relevant scientific or technical discipline or sufficient technical depth or professional experience.
• Demonstrated experience with US regulatory requirements, experience supporting regulatory inspections, and strong experience with good manufacturing practices.
• Knowledge of product lifecycle compliance activities, including regulatory commitments, submissions, registrations, license renewals, change controls, product reviews, stability programs, and associated reporting requirements.

Qualifications

• Advanced degree in a scientific, technical, or regulatory discipline.
• Experience managing quality agreements and supplier or third-party oversight.
• Experience with periodic product review programs and product lifecycle compliance activities.
• Good working knowledge of GSK marketed products (US & International) with emphasis on Chemistry, Manufacturing and Controls (CMC).
• Strong written and verbal communication skills and comfort preparing leadership reports and dashboards.
• Experience in continuous improvement or operational excellence programs.

Skills

• Data Integrity
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

Potentially also include About the Zebulon Site as a paragraph under About the role. We need to ensure we don't repeat job title. Not included. We must not include any application instructions. Check for duplicated lines: we should avoid repeating same content. Now produce HTML. We'll need to escape any HTML special characters? Not needed. Let's craft the About the role paragraph: combine Business Introduction and Position Summary. Business Introduction: "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." Position Summary: "You will lead a team responsible for the site Product Lifecycle Compliance function, including the Regulatory Compliance and Stability Operations & Retains Management teams, as well as ownership of the Periodic Product Review (PPR) program. You will partner across the site and externally with GSK Regulatory Affairs, LOCs, other GSK sites, and relevant business functions to implement regulatory and stability requirements and support compliant product supply. We value clear decision making, practical problem solving, and coaching. This role offers strong growth, visible impact on patient safety, and the chance to help unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Coach, develop and lead the Regulatory Compliance and Stability Operations & Retains Management teams. Providing leadership to ensure regulatory commitments, submissions, license renewals, registrations, quality agreements, change controls, product reviews, stability studies, stability reporting, sample management, and retain storage activities remain compliant with global health authority and GSK requirements. Maintaining inspection readiness across the teams while driving capability development, effective decision-making, and continuous improvement. Provide site support for health authority and internal inspections and maintain ongoing inspection readiness across Regulatory Compliance and Stability Operations & Retains Management activities." We can combine but avoid duplication: The Position Summary already includes some responsibilities list; but we will keep responsibilities separate. Thus About the role paragraph will be Business Introduction + Position Summary (maybe truncated to avoid repeating responsibilities). We'll include the Position Summary up to before "These responsibilities include some of the following:" because that leads into responsibilities list. We'll cut off before that. Thus Position Summary text: "You will lead a team responsible for the site Product Lifecycle Compliance function, including the Regulatory Compliance and Stability Operations & Retains Management teams, as well as ownership of the Periodic Product Review (PPR) program. You will partner across the site and externally with GSK Regulatory Affairs, LOCs, other GSK sites, and relevant business functions to implement regulatory and stability requirements and support compliant product supply. We value clear decision making, practical problem solving, and coaching. This role offers strong growth, visible impact on patient safety, and the chance to help unite science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career." We'll combine. Now Responsibilities list: from the "Responsibilities" section after "These responsibilities include some of the following:" Actually there is a separate "Responsibilities" heading later with list. We'll use that list. List items: - Own and manage the site Periodic Product Review (PPR) program and schedule, ensuring monthly product review activities are completed accurately, compliantly, and within established timelines. - Oversee regulatory assessment of proposed technical changes through the Change Control System, providing guidance on submission impact, Regulatory Implementation Strategy (RIS), registered commitments, and change scope. - Partner with GSK Regulatory Affairs, LOCs, Quality, other GSK sites, and relevant business functions to maintain licenses, registrations, regulatory commitments, submissions, and market requirements in compliance with applicable health authority and GSK requirements. - Oversee Quality Agreements, IQAs, and QAPRSs associated with US-marketed products managed by Zebulon, products supplied by Zebulon, and CMO-managed products. - Oversee the receipt, storage, setup, delivery, and control of stability samples in accordance with approved registered protocols, methods, specifications, market requirements, GMP expectations, and established timelines. - Ensure annual stability commitments, stability data reporting, sample storage, and retain storage requirements are accurately defined, maintained, monitored, and reported to applicable regulatory authorities, local site QA, and other GSK sites as required. Now Schedule: "Work arrangement: This role is hybrid. You will be expected to work on-site regularly, with flexibility for remote work as agreed with your manager." Now Requirements (Basic Qualification) list: - 8+ years experience in a GMP-regulated pharmaceutical environment, with 5+ years of relevant experience in a quality or compliance role. - Experience leading people and cross-functional activities. - Bachelor’s degree in Pharmaceutical