Compliance Specialist

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.
• 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.

Requirements

• 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.
• 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 colla

Benefits

Additional Information

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.

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