QC Microbiology Group Leader

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary
You will lead team of Quality control scientists responsible for sampling, testing, method validation, and facility monitoring (as applicable) in a GMP environment. Demonstrate broad and thorough knowledge of scientific principles and QC processes and pharmaceutical products. Strong communication skills to generate various types of technical documents such as investigation reports and SOPs and Leadership skills to guide and/or collaborate with others to achieve their goals and expectations. Ensure that the QC testing and method validation of all products/value streams is performed to GMP and company standards (Analytical Chemistry/Microbiological & facility testing as applicable).

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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).

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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 Qualification
If you have the following characteristics, it would be a plus:

• 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.

About the Zebulon Site

GSK's Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest.

Key differentiators about GSK and Zebulon:

• Our commitment to inclusion is seen as a critical advantage of ours

• Our focus on cultivating a positive work environment that cares for our employees

• Demonstrated opportunities for continued career growth driven by individual ambition

• Leaders that care about their teams and growth of both individuals and the company

• A priority focused on Safety and Quality

• Clean and GMP compliant work environment

• Onsite cafeteria

• Onsite gym

• Temperature-controlled climate

• Licensed, onsite Health & Wellness clinic

Why You?
This role has 100% on-site requirements. We welcome people who are motivated to lead, learn and make a measurable difference. We value inclusion and practical leadership that develops others.

How to apply
If this role matches your experience and ambitions, we would like to hear from you. Please submit your CV and a short note describing how you led a lab team and delivered measurable improvements. We welcome applicants from all backgrounds and encourage those who value inclusion to apply.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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