QC Group Leader

Business IntroductionWe 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 SummaryYou 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. E nsure 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).ResponsibilitiesThis 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).Why You?Basic QualificationWe are seeking professionals with the following required skills and qualifications to help us achieve our goals:Bachelor’s Degree + 4 years relevant pharmaceutical experience orAssociate's degree + 6 years relevant pharmaceutical experience orHigh 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 of providing QC testing support to at least one value streamPreferred QualificationIf you have the following characteristics, it would be a plus:Master’s degree in a relevant scientific field.Developing knowledge and application of the Quality Management System (QMS).Knowledge of company products and quality impact as it relates to those 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.Expert in portfolio of products. Discuss and defend product data generated and specifications.Experience of leading work in teams to improve processes or resolve problems using OE/GPS tools.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 SiteGSK’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 oursOur focus on cultivating a positive work environment that cares for our employeesDemonstrated opportunities for continued career growth driven by individual ambitionLeaders that care about their teams and growth of both individuals and the companyA priority focus on Safety and QualityClean and GMP compliant work environmentOnsite cafeteriaOnsite gymTemperature-controlled climateLicensed, onsite Health & Wellness clinicWork arrangement100% on site responsibilities.What we valueWe value clear communication, curiosity, and teamwork. We welcome people who are coachable, accountable, and focused on doing the right thing for patients. We are committed to inclusion and to creating a workplace where different perspectives are heard and respected.How to applyIf this role resonates with you, please submit your resume and a short note describing a recent leadership example and the impact you delivered. We look forward to learning how you can help us deliver high quality results for patients and grow your career at GSK.#LI-GSKPlease 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.If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - View email address on click.appcast.io 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr GlaxoSmithKline