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.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 ReadinessSupport as appropriate product and technology transfers to GSK or CMORepresent Quality R&D department positions/opinions views ablish good GSK network and educate and influence by his/her behaviour, compliance to good quality practicesProvide 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 remaure 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 capabilitiesStrong interpersonal skills with demonstrated ability to engage, empower and influence peopleAbility to make decisions even under pressure and navigate in grey zonesAbility to define priorities and critical thinking to understand risks and escalateAbility to analyse data, identify trends and draw conclusions; excellent problem solving skills.Extensive knowledge of cGMPs, FDA guidelines, compliance requirements, facility registration, validation, regulatory submissions and regulatory reporting requirements.Strong knowledge and application of the QMSOperational Excellence tools and KPI managementAgility to operate in a matrix organisation between R&D & GSCStrong presentation skills - Capability to present in front of a national and international panel.SkillsData Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical WritingWhy 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.
19 days ago