Quality R&D GMP Ops Senior Director at GSK in Upper Merion

Job description

Quality R&D GMP Ops Senior Director At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D The QRD Operations Sr Director is leading the team in charge of the Quality for R&D GMP manufacturing Pilot Plants, including manufacturing, storage, distribution and validation activities. The QRD Operations Sr Director will ensure all production steps for seeds and cells banks, API, drug substances and drug products are manufactured in compliance with cGMP/cGDP. The QRD Operations Sr Director will provide clear direction, build team and people capability; will provide leadership for change initiatives involving processes, product, technologies, digitalization and people to ensure GSK meets its strategic objectives and acceleration to product launches. Key Responsibilities: Lead the quality organization in R&D supporting GMP manufacturing, storage and distribution activities, ensuring all production steps for seeds and cell banks, API, drug substances and drug products, including the release of intermediate batches are done in compliance with cGMP/cGDP (this include facilities, calibration and measure, maintenance, qualification, validation, manufacturing, storage, distribution, material and media preparation, technical services, sterility assurance,…) Ensure implementation of high-quality processes and systems (QMS) to support full compliance to cGMP, regulatory expectations and GSK standards, managing risks as appropriate. Ensure the Quality Governance, Quality Oversight and Management of regulatory observations, deviations, CAPA, Change Control, written standards, trainings, management monitoring. Ensure that quality issues are adequately managed with identification and characterization of the issue, impact evaluation on quality, safety and efficacy as well as potential impact on clinical data, ensuring timely escalation to upper management including remediation plan proposals. Identify proactively and manage potential quality and business risks. Host quality Inspections and quality audits, ensure Inspection Readiness Support as appropriate product and technology transfers to GSK or CMO Represent Quality R&D department positions/opinions views in all meetings, establish good GSK network and educate and influence by his/her behaviour, compliance to good quality practices Provide clear direction, build team and people capability, career development; provide leadership for change initiatives involving processes, product, technologies, digitalization, culture and people. As leader, be responsible to ensure all people remain safe at all time, ensure preventive measures are implemented and employees have the necessary skills and medical aptitude, manage EHS risks, EHS incidents. Basic Qualifications: Master’s degree in Bioengineering or related field. Ten or more years of quality experience in a regulated environment. Five or more years of experience in cGMP globally and new product introduction. Three or more years of experience determining phase appropriate requirements for clinical supply and commercial PAI requirements for commercial. Preferred Qualifications: PhD in bioengineering or related field. Strong leadership skills to motivate, engage and develop capabilities Strong interpersonal skills with demonstrated ability to engage, empower and influence people Ability to make decisions even under pressure and navigate in gre