Compliance Specialist
GSK
June 25, 2026
Remote friendly (Marietta, PA)
United States
Corporate Functions
Position Summary
You will help ensure manufacturing and supply operations meet quality and regulatory expectations by leading investigations of deviations and driving corrective actions with manufacturing, quality, and technical teams.
Responsibilities
- Lead investigations of deviations/unplanned events; use root cause analysis to define CAPAs and preventive actions.
- Own CAPA and change control activities to resolution with cross-functional stakeholders.
- Review/draft operational and quality documentation (batch records, SOPs, training records, investigation reports).
- Prepare and present investigation findings to relevant teams/management.
- Support continuous improvement (process improvements and site quality programs).
- Provide compliance guidance/training to operations staff.
- Develop/maintain procedures, validation/investigational protocols, PQR inputs, and training materials to improve standardization and right-first-time performance.
- Lead/document EHS and quality investigations; apply DMAIC; implement CAPAs/change controls; execute change controls and internal audit actions.
- Analyze process/equipment data (Aveva PI/PI Vision) for trend reports/alerts.
- Build Power BI dashboards for EHS/quality/performance KPIs.
- Facilitate GPS/continuous improvement (Leader Standard Work, tiered performance management, DMAIC, 5S) across the value stream.
Basic Qualifications
- 3–5 years’ experience in GMP biopharmaceutical/pharmaceutical manufacturing, MSAT, quality, or EHS.
- Bachelor’s degree in scientific/engineering/related field (or equivalent).
- 2+ years in regulated manufacturing with GMP exposure.
- Experience with investigations/RCA/compliance roles.
- Experience with quality system elements (deviations, CAPA, change control, document control).
Preferred Qualifications
- SAP or similar systems; hands-on regulated manufacturing experience.
- Cross-functional collaboration and task prioritization.
- RCA tools (5 Whys, fishbone, FMEA) and continuous improvement methods.
- Audit/regulatory authority experience; Microsoft Office/Excel skills.
- Experience training/coaching non-quality staff.
How to Apply
Apply now and describe how your experience matches the role.
You will help ensure manufacturing and supply operations meet quality and regulatory expectations by leading investigations of deviations and driving corrective actions with manufacturing, quality, and technical teams.
Responsibilities
- Lead investigations of deviations/unplanned events; use root cause analysis to define CAPAs and preventive actions.
- Own CAPA and change control activities to resolution with cross-functional stakeholders.
- Review/draft operational and quality documentation (batch records, SOPs, training records, investigation reports).
- Prepare and present investigation findings to relevant teams/management.
- Support continuous improvement (process improvements and site quality programs).
- Provide compliance guidance/training to operations staff.
- Develop/maintain procedures, validation/investigational protocols, PQR inputs, and training materials to improve standardization and right-first-time performance.
- Lead/document EHS and quality investigations; apply DMAIC; implement CAPAs/change controls; execute change controls and internal audit actions.
- Analyze process/equipment data (Aveva PI/PI Vision) for trend reports/alerts.
- Build Power BI dashboards for EHS/quality/performance KPIs.
- Facilitate GPS/continuous improvement (Leader Standard Work, tiered performance management, DMAIC, 5S) across the value stream.
Basic Qualifications
- 3–5 years’ experience in GMP biopharmaceutical/pharmaceutical manufacturing, MSAT, quality, or EHS.
- Bachelor’s degree in scientific/engineering/related field (or equivalent).
- 2+ years in regulated manufacturing with GMP exposure.
- Experience with investigations/RCA/compliance roles.
- Experience with quality system elements (deviations, CAPA, change control, document control).
Preferred Qualifications
- SAP or similar systems; hands-on regulated manufacturing experience.
- Cross-functional collaboration and task prioritization.
- RCA tools (5 Whys, fishbone, FMEA) and continuous improvement methods.
- Audit/regulatory authority experience; Microsoft Office/Excel skills.
- Experience training/coaching non-quality staff.
How to Apply
Apply now and describe how your experience matches the role.