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 deviations, drive corrective actions, and work closely with manufacturing, quality, and technical teams. We value clear problem solvers who communicate well, act with integrity, and enjoy improving systems. Joining this team gives you the chance to grow your technical and leadership skills while contributing 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. Use root cause analysis to identify causes and propose robust corrective and preventive actions. Own and drive CAPA and change control activities to resolution, working with cross-functional stakeholders. Review and draft operational and quality documentation such as batch records, SOPs, training records, and investigation reports. Prepare clear investigation reports and present findings to relevant teams and management. Support continuous improvement initiatives in manufacturing, including participation in process improvements and site quality programs. Provide guidance and training to operations staff on compliance-related topics to strengthen a culture of compliance. Develop, maintain, and improve written procedures, validation/investigational protocols, PQR inputs, and training materials that make work simple, standardized, and error-proof, supporting >90% right-first time and 0 deviations from human error. Lead and document EHS and quality investigations; apply structured problem-solving (DMAIC) to identify true root causes; define and implement robust CAPAs and change controls, ensuring 0 overdue quality system events (deviations, CAPAs, change controls, complaints, audits, PQRs), 0 data integrity events, 0 SIFs, proactive pSIFs >75% of pSIFs recorded, and 0 unplanned maintenance interventions. Plan, execute, and document change controls and internal audit actions in partnership with EHS, Quality, MSAT, Maintenance, and Operations, ensuring 0 overdue internal audits and sustainable closure of findings. Recover and analyze process and equipment data from Aveva PI and PI Vision to design trend reports and alerts that proactively identify risks. Design, build, and maintain Power BI dashboards that display critical EHS, quality, and performance KPIs (e.g., CTRP, CTP, RFT, cost of poor quality, engagement), enabling fact-based tiered performance management and continuous reduction of the cost of poor quality. Lead and facilitate GPS and continuous improvement activities (Leader Standard Work, tiered performance management, DMAIC problem solving, and 5S) that improve process capability, engagement (>90%), and standardization across the Marietta DS Value Stream. Collaborate with value stream leaders and functional partners to prioritize and sequence compliance and improvement work in line with supply commitments, ensuring 100% CTRP and 100% CTP and strengthening Marietta’s position as a center of excellence for MAPS DS production. Basic Qualifications: 3–5 years of experience in GMP biopharmaceutical or pharmaceutical manufacturing, MSAT, quality, or EHS. Bachelor’s degree required in a scientific, engineering, or related field, or equivalent experience. Minimum 2 years of experience in a regulated manufacturing environment with exposure to good manufacturing practices. Experience performing investigations, root cause analysis, or working in a compliance role. Experience with of quality system elements such as deviations, CAPA, change control, and document control. Preferred Qualifications: If you have the following characteristics, it would be a plus: SAP or similar enterprise systems for recording quality events. Prior hands-on experience in pharmaceutical, biologics, or related regulated manufacturing operations. Ability to work collaboratively within cross-functional teams and to prioritize multiple tasks. Familiarity with formal RCA tools (5 Whys, fishbone, FMEA) and continuous improvement methods. Experience supporting audits or interacting with regulatory authorities. 'Proficiency with Microsoft Office applications, especially Excel for basic data analysis and tracking. Delivering training and coaching non-quality staff on compliance processes. Work Arrangement: This role is based in the United States and is on-site or hybrid depending on the site and business needs. Specific location and hybrid details will be shared during the hiring process. How to Apply: If you are ready to grow your compliance skills and help improve manufacturing quality, we want to hear from you. Apply now and tell us how your experience matches this role. We welcome applicants from all backgrounds and encourage people who bring different perspectives to apply. #LI-GSK #GSKCareers 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 notice to Employment businesses/ Agencies GSK does not accept referrals from employm