QC Group Leader
GSK
4 hours ago
On-site
Zebulon, NC
Operations
Position Summary
You will lead a team of Quality Control scientists responsible for sampling, testing, method validation, and facility monitoring (as applicable) in a GMP environment. Ensure QC testing and method validation of all products/value streams are performed to GMP and company standards (Analytical Chemistry/Microbiological & facility testing as applicable).
Responsibilities
- Direct, document, and approve laboratory investigations for out-of-specification or atypical results.
- Provide leadership in setting connections between specific, measurable targets and site strategy.
- Use a participative management style to empower the team in objectives, performance management, problem solving, decision making, and continuous improvement.
- Lead development of staff performance plans, including a capability plan and departmental goals.
- Lead daily improvements related to safety, quality, customer service, and cost.
- Demonstrate knowledge of the pharmaceutical industry, drug development, and regulatory requirements; evaluate manufacturing, packaging, and cleaning validation protocols for scientific merit.
- Provide leadership and decision-making on interdepartmental project teams.
- Ensure safe laboratory practices and current GMP compliance; maintain cleanliness and reduce waste of laboratory resources.
- Create/revise departmental SOPs, technical reports, product specifications, and analytical test methods to comply with QMS, CAPs/ATS, and industry guidelines.
- Serve key roles in stability protocols, customer complaint investigations, annual review, retain samples, instrument calibration, and act as a main point of contact for internal/external audits (e.g., FDA, MHRA, GMP-A).
Basic Qualifications (Required)
- Bachelor’s degree + 4 years relevant pharmaceutical experience OR Associate’s degree + 6 years relevant pharmaceutical experience OR High School + 10 years relevant pharmaceutical experience.
- 5+ years’ experience in a GMP-regulated laboratory environment.
- 2+ years’ experience supervising or leading a laboratory team.
- Experience providing QC testing support to at least one value stream.
Preferred Qualifications
- Master’s degree in a relevant scientific field.
- Experience with QMS (development and application).
- Knowledge of company products and their quality impact.
- Command of ICH guidance, GMP requirements, and FDA/EMEA regulations; approve lab study protocols acceptable to regulators.
- Expertise across a product portfolio; ability to discuss/defend product data and specifications.
- Experience using OE/GPS tools to improve processes or resolve problems.
- Operational knowledge of analytical chemistry/microbiology (as applicable) and complex laboratory equipment.
- Full understanding of GMP principles in a laboratory environment.
- Effective verbal and written communication to multiple audience levels.
- Experience approving analytical equipment validation and test method validation activities.
- Strong leadership and ability to build win/win partnerships and collaborate across departments.
- Technical expertise in analytical methodologies (e.g., HPLC, spectroscopy, dissolution, physical testing, hardness) and training practices OR microbiological methodologies (e.g., challenges, identification, facility monitoring/response) and training practices.
How to Apply
Submit your resume and a short note describing a recent leadership example and the impact you delivered.
You will lead a team of Quality Control scientists responsible for sampling, testing, method validation, and facility monitoring (as applicable) in a GMP environment. Ensure QC testing and method validation of all products/value streams are performed to GMP and company standards (Analytical Chemistry/Microbiological & facility testing as applicable).
Responsibilities
- Direct, document, and approve laboratory investigations for out-of-specification or atypical results.
- Provide leadership in setting connections between specific, measurable targets and site strategy.
- Use a participative management style to empower the team in objectives, performance management, problem solving, decision making, and continuous improvement.
- Lead development of staff performance plans, including a capability plan and departmental goals.
- Lead daily improvements related to safety, quality, customer service, and cost.
- Demonstrate knowledge of the pharmaceutical industry, drug development, and regulatory requirements; evaluate manufacturing, packaging, and cleaning validation protocols for scientific merit.
- Provide leadership and decision-making on interdepartmental project teams.
- Ensure safe laboratory practices and current GMP compliance; maintain cleanliness and reduce waste of laboratory resources.
- Create/revise departmental SOPs, technical reports, product specifications, and analytical test methods to comply with QMS, CAPs/ATS, and industry guidelines.
- Serve key roles in stability protocols, customer complaint investigations, annual review, retain samples, instrument calibration, and act as a main point of contact for internal/external audits (e.g., FDA, MHRA, GMP-A).
Basic Qualifications (Required)
- Bachelor’s degree + 4 years relevant pharmaceutical experience OR Associate’s degree + 6 years relevant pharmaceutical experience OR High School + 10 years relevant pharmaceutical experience.
- 5+ years’ experience in a GMP-regulated laboratory environment.
- 2+ years’ experience supervising or leading a laboratory team.
- Experience providing QC testing support to at least one value stream.
Preferred Qualifications
- Master’s degree in a relevant scientific field.
- Experience with QMS (development and application).
- Knowledge of company products and their quality impact.
- Command of ICH guidance, GMP requirements, and FDA/EMEA regulations; approve lab study protocols acceptable to regulators.
- Expertise across a product portfolio; ability to discuss/defend product data and specifications.
- Experience using OE/GPS tools to improve processes or resolve problems.
- Operational knowledge of analytical chemistry/microbiology (as applicable) and complex laboratory equipment.
- Full understanding of GMP principles in a laboratory environment.
- Effective verbal and written communication to multiple audience levels.
- Experience approving analytical equipment validation and test method validation activities.
- Strong leadership and ability to build win/win partnerships and collaborate across departments.
- Technical expertise in analytical methodologies (e.g., HPLC, spectroscopy, dissolution, physical testing, hardness) and training practices OR microbiological methodologies (e.g., challenges, identification, facility monitoring/response) and training practices.
How to Apply
Submit your resume and a short note describing a recent leadership example and the impact you delivered.