QC Group Leader

Position Summary You will lead a team of Quality Control scientists responsible for sampling, testing, method validation, and facility monitoring in a GMP environment. You demonstrate a 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 QC testing and method validation of all products/value streams is performed to GMP and company standards. 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 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 project 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 serve as main point of contact for internal and external audits (e.g. FDA, MHRA, GMP‑A). Basic Qualifications 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. 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 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. Work Arrangement 100% on site responsibilities. Equal Opportunity Employer Statement 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, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr NCBiotech