Compliance Specialist

Responsibilities

• 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.
  • 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).
  • 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.

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 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.

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. #GSKCareers

GSK US Benefits Summary

To learn more about the comprehensive benefits program GSK offers US employees, please visit the GSK US Benefits Summary page.