Product Release Leader
GSK
14 days ago
On-site
Zebulon, NC
Operations
Position Summary
Provide operational quality support and oversight to all GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI), Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
Responsibilities
- Ensure adherence to cGxP standards and independently oversee GxP processes.
- Review and release products manufactured/packaged in compliance with local and regulatory requirements.
- Improve quality effectiveness by enabling a strong quality culture and leading continuous improvement.
- Maintain presence and be accountable for quality decision-making and quality escalations.
- Provide quality oversight across assigned GMP areas; manage initial quality issues and assess work orders/atypical comments/impacts for deviations.
- Review, release, and second check batch record documentation for compliance with cGMPs, SOPs, and internal/regulatory requirements; support Good Documentation Practice (GDP) and ALCOA++ data integrity.
- Provide real-time guidance/observation during GMP activities; support/lead problem solving, root cause analysis, and CAPA identification.
- Perform spot-checks of production, testing, cleaning, and maintenance; ensure facilities remain in good state and escalate deviations.
- Collaborate with cross-functional teams to resolve quality issues and implement CAPAs; role model GPS and foster a Quality Starts with Me (QSWM) culture.
- Communicate effectively and provide on-call support as required.
- Create/review/second check CoA/CoC certificates.
Work Arrangement
- 100% on-site; some nights and weekends expected.
Basic Qualification (Required)
- Bachelor’s degree and 4+ years of GMP pharmaceutical experience.
- 4+ years in pharmaceutical manufacturing/quality/QC applying QMS and GMP.
- Experience with deviations, CAPA, change control, and document control.
Preferred Qualification
- Degree in scientific/engineering/quality discipline.
- Independent and strong team player; good cGMP and regulatory knowledge.
- Initiative, analytical problem-solving, organization, adaptability, and ability to prioritize.
- Proficient with IT applications (e.g., MERP, Microsoft Office, Power BI, VQD).
- Clear communication, coaching ability, continuous improvement mindset.
Application Instructions
- Apply and tell how your experience fits the role; see GSK US Benefits Summary for benefits details.
Provide operational quality support and oversight to all GMP areas including Oral Solid Dose (OSD), Metered Dose Inhaler (MDI), Multi-Dose Powder Inhaler (MDPI), Laboratories, Warehouse, and Facility/Utility areas.
Responsibilities
- Ensure adherence to cGxP standards and independently oversee GxP processes.
- Review and release products manufactured/packaged in compliance with local and regulatory requirements.
- Improve quality effectiveness by enabling a strong quality culture and leading continuous improvement.
- Maintain presence and be accountable for quality decision-making and quality escalations.
- Provide quality oversight across assigned GMP areas; manage initial quality issues and assess work orders/atypical comments/impacts for deviations.
- Review, release, and second check batch record documentation for compliance with cGMPs, SOPs, and internal/regulatory requirements; support Good Documentation Practice (GDP) and ALCOA++ data integrity.
- Provide real-time guidance/observation during GMP activities; support/lead problem solving, root cause analysis, and CAPA identification.
- Perform spot-checks of production, testing, cleaning, and maintenance; ensure facilities remain in good state and escalate deviations.
- Collaborate with cross-functional teams to resolve quality issues and implement CAPAs; role model GPS and foster a Quality Starts with Me (QSWM) culture.
- Communicate effectively and provide on-call support as required.
- Create/review/second check CoA/CoC certificates.
Work Arrangement
- 100% on-site; some nights and weekends expected.
Basic Qualification (Required)
- Bachelor’s degree and 4+ years of GMP pharmaceutical experience.
- 4+ years in pharmaceutical manufacturing/quality/QC applying QMS and GMP.
- Experience with deviations, CAPA, change control, and document control.
Preferred Qualification
- Degree in scientific/engineering/quality discipline.
- Independent and strong team player; good cGMP and regulatory knowledge.
- Initiative, analytical problem-solving, organization, adaptability, and ability to prioritize.
- Proficient with IT applications (e.g., MERP, Microsoft Office, Power BI, VQD).
- Clear communication, coaching ability, continuous improvement mindset.
Application Instructions
- Apply and tell how your experience fits the role; see GSK US Benefits Summary for benefits details.