Product Release Leader
GSK
August 15, 2026
On-site
Zebulon, NC
IT
Position Summary
- Provide operational quality support and oversight to GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
Responsibilities
- Ensure adherence to cGxP standards via independent oversight of GxP processes.
- Review, release, and provide second checks of batch record documentation for compliance with cGMPs, SOPs, and internal/regulatory requirements; ensure GDP/data integrity (ALCOA++).
- Maintain presence as first line of contact for quality issues; perform quality decision-making for work order assessments, atypical comments, and initial deviation impact assessments.
- Provide real-time guidance and observations during GMP activities to detect potential quality issues; support/lead problem solving, root cause analysis, and CAPA identification.
- Perform spot-checks across GMP areas (production, testing, cleaning, maintenance); ensure facilities are in a good state and deviations are escalated with remedial actions.
- Collaborate cross-functionally to resolve quality issues, implement CAPAs, and drive continuous improvement.
- Role model GPS standards and foster a Quality Starts with Me (QSWM) culture; coach others.
- Communicate effectively and provide on-call support as required.
- Create/review/second-check CoA/CoC certificates aligned with market requirements and GSK standards.
Qualifications
- Bachelor’s Degree and 4+ years of GMP pharmaceutical experience.
- 4+ years in Pharmaceutical Manufacturing, Quality, or QC; apply QMS and GMP principles.
- Experience with deviations, CAPA, change control, and document control.
Preferred
- Scientific/engineering/quality bachelor’s degree.
- Knowledge of cGMP and regulatory requirements; strong analytical problem-solving and collaboration.
- Proficient with IT applications (e.g., MERP, Microsoft Office, Power BI, VQD).
Work arrangement
- 100% on-site; some nights and weekends.
Application
- Apply and explain how your experience fits the role.
- Provide operational quality support and oversight to GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI) and Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
Responsibilities
- Ensure adherence to cGxP standards via independent oversight of GxP processes.
- Review, release, and provide second checks of batch record documentation for compliance with cGMPs, SOPs, and internal/regulatory requirements; ensure GDP/data integrity (ALCOA++).
- Maintain presence as first line of contact for quality issues; perform quality decision-making for work order assessments, atypical comments, and initial deviation impact assessments.
- Provide real-time guidance and observations during GMP activities to detect potential quality issues; support/lead problem solving, root cause analysis, and CAPA identification.
- Perform spot-checks across GMP areas (production, testing, cleaning, maintenance); ensure facilities are in a good state and deviations are escalated with remedial actions.
- Collaborate cross-functionally to resolve quality issues, implement CAPAs, and drive continuous improvement.
- Role model GPS standards and foster a Quality Starts with Me (QSWM) culture; coach others.
- Communicate effectively and provide on-call support as required.
- Create/review/second-check CoA/CoC certificates aligned with market requirements and GSK standards.
Qualifications
- Bachelor’s Degree and 4+ years of GMP pharmaceutical experience.
- 4+ years in Pharmaceutical Manufacturing, Quality, or QC; apply QMS and GMP principles.
- Experience with deviations, CAPA, change control, and document control.
Preferred
- Scientific/engineering/quality bachelor’s degree.
- Knowledge of cGMP and regulatory requirements; strong analytical problem-solving and collaboration.
- Proficient with IT applications (e.g., MERP, Microsoft Office, Power BI, VQD).
Work arrangement
- 100% on-site; some nights and weekends.
Application
- Apply and explain how your experience fits the role.