Compliance Specialist

Job description

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 help ensure our manufacturing and supply operations meet quality and regulatory expectations. You will lead investigations of unplanned events, drive corrective actions, and support change controls. You will work with manufacturing, quality, engineering, and other partners. We value clear problem solvers who act with integrity, communicate simply, and enjoy improving systems. This role gives you growth, meaningful impact and a chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Lead investigations of deviations and unplanned events, using structured root cause analysis. Own and drive corrective and preventive actions (CAPA) to timely resolution with cross-functional partners. Prepare clear investigation reports and present findings to operations, quality and management. Manage change controls and update operational documents such as SOPs, batch records and training materials. Support continuous improvement initiatives to reduce repeat events and improve right-first-time performance. Train and coach staff on compliance to strengthen a culture of compliance. Perform root cause analysis which may require facilitation of cross functional teams to investigate deviations and determine robust corrective actions, lead problem solving and support recurrent and complex deviations using DMAIC. Timely completion of Engineering quality system action plans. This includes writing, revising, or coordinating the efforts for change controls, SOPs, audits, and training documentation. Represent the Engineering department at the site change control meetings. Prepare and track change controls to make improvements outside of deviations. Include assessment of Global QMS (Quality Management System), Engineering, and EHS standards in creation and revision of Engineering SOP's to align with global requirements and requests.  Track, trend, and evaluate Engineering misalignments and work to determine root causes. This includes tracking and trending progress of CAPA's (EHS and GMP) using a routine reporting system. Interact and coordinate with appropriate personnel including manufacturing, Supply Chain, Engineering, QA/QC, regulatory, etc. Communicate immediately with QA, Operations, Supply Chain, and EHS management for all Engineering discrepancies that impact product quality or safety. Develop internal GMP and EHS audit schedules (including area to be audited) on a yearly basis. Interact with external regulatory authorities as needed during routine and non-routine audits. Perform all job responsibilities in compliance with the GSK safety procedures and all applicable EHS regulations, SOP's, and industry practices. Monitor process health through various governances, scorecards, data trending, etc. and problem solve or escalate issues when out of acceptable state. Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals Scientific, technical, engineering or related field, or equivalent experience. B.S or B.A in a technical discipline, preferably in Microbiology, Biology/Virology, Biochemistry, Chemistry, Engineering or Pharmacy. Degree in other discipline if sufficient technical depth has been achieved from professional experience. Minimum of 3 years pharmaceutical experience investigating manufacturing deviations either in a QA or manufacturing role. Experience performing investigations, root cause analysis or working in a compliance role. Familiarity with quality system elements such as deviations, CAPA, change control and document control. Preferred Qualifications: Hands-on experience with SAP or similar quality/event management systems. Proficiency with Microsoft Office, especially Excel for data tracking and basic analysis. Familiarity with formal RCA tools (5 Whys, fishbone, FMEA) and continuous improvement methods. Experience supporting audits or interacting with regulatory authorities. Experience delivering training or coaching non-quality staff on compliance processes. What we offer: You will join a team focused on continuous learning and technical growth. You will influence processes that protect patient safety and product quality. You will gain exposure to cross-functional work and real-world problem solving. Ready to apply? If this role matches your skills and ambition, we encourage you to apply. Tell us how your experience and values align with this role and how you can help us get ahead of disease together. We welcome applicants from all backgrounds and encourage people who bring different perspectives to apply. Skills Data Integrity, Detail-Oriented, Digital Fluency, Emergency Response, Financial Acumen, GxP Regulations, Lean Management, Manufacturing Processes, Problem Solving, Production Management, Project Coordination, Quality Compliance, Regulatory Compliance, Risk Awareness, Site Operations Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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 (including family medical history), military service or any basis prohibited under federal, state or local law. Important notic