GSK · 13 hours ago
QC Microbiology Group Leader
Zebulon, NC
Full-time
Onsite
Senior Level
5+ years expGSK is a global biopharma company dedicated to improving health through innovative medicines and vaccines. The QC Microbiology Group Leader will oversee a team of quality control scientists in a GMP environment, ensuring compliance with testing and validation standards while fostering team development and continuous improvement.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Direct, document and approve laboratory investigations for out of specification or atypical results
Provide clear leadership in setting connections between specific, measurable targets in the area with site strategy
Adopt participative management style that empowers the team by involving them in setting objectives, performance management, problem solving, decision making and continuous improvement
Provide clear leadership in the development of staff performance plans including a capability plan and departmental goals
Lead the team to deliver daily improvements (relating to safety, quality, customer service and cost)
Demonstrate broad knowledge (e.g., various dosage forms) of the pharmaceutical industry, the drug development process and current regulatory requirements and environment
Evaluate manufacturing, packaging and cleaning validation protocols for scientific merit
Participate on interdepartmental projects teams within the site by providing leadership and decision making
Ensure safe laboratory practices and current GMPs are followed
Maintain high standards of tidiness and cleanliness in all areas and actively reduce waste of laboratory resources
Create and revise departmental SOPs, technical reports, product specifications and analytical test methods
Ensure these comply with above site documents (e.g. QMS, CAPs/ATS, Industry guidelines, etc.)
Serve key roles in the programs involving but not limited to stability protocols, customer complaint investigations, annual review, retain samples, and instrument calibration and main point of contact for internal and external audits (e.g. FDA, MHRA, and GMP-A)
Qualification
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 regulated laboratory with hands-on microbiology testing
Experience of providing QC testing support to at least one value stream
Developing knowledge and application of the Quality Management System (QMS)
Experience leading work in teams to improve processes or resolve problems using OE/GPS tools
Experience in portfolio of products
Demonstrated ability to participate in product projects - command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations. Approve lab study protocols and ensure they are designed to be acceptable to regulators
Knowledge of company products and quality impact as it relates to those products
Preferred
Master's degree in microbiology, biology or a related field
Ability to Discuss and defend product data generated and specifications
Operational knowledge of analytical chemistry/microbiology (as applicable), complex laboratory equipment, including ability to diagnose problems and identify appropriate actions
Full understanding of the requirements and application of GMP principles in a laboratory environment
Effective verbal and written communication on an individual and group basis targeted to appropriately audiences of several levels within GMS
Approve validation of analytical equipment and activities related to test method validation
Strong leadership skills with an ability to form strong win/win partnerships. A demonstrated willingness to collaborate with external department colleagues to share best practices and exchange ideas. Support other teams when required
Technical expertise in a broad range of analytical methodologies from core HPLC techniques, sample preparation techniques (including automation), spectroscopy, dissolution testing, physical testing, hardness etc. and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable). OR Technical expertise in a broad range of microbiological methodologies from microbial challenges, identification, sample preparation techniques, facility monitoring/response etc. and understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard
Benefits
Onsite cafeteria
Onsite gym
Temperature-controlled climate
Licensed, onsite Health & Wellness clinic
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase