Global C&Q Director
5 ore fa
Global C&Q DirectorLocation: GSK HQ, Belgium-Wavre, Italy - Parma, Rosia, UK - Angus - Montrose, UK - County Durham - Barnard Castle, UK - North Ayrshire - IrvinePosted Date: Dec *******Business IntroductionGSK remains committed to achieving bold commercial ambitions for the future.By ****, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally.Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems.Our diverse portfolio consists of vaccines, specialty medicines, and general medicines.Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.Position SummaryThe Global C&Q Director will lead and manage the consistent deployment of best-in-class capability and capacity of commissioning and qualification activities within the project portfolio under the accountability of Global Capital Projects group (GCP).This role is responsible for ensuring that all project equipment, systems, and processes consistently meet regulatory and company standards to ensure product quality and patient safety.The Global C&Q Director will work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure the delivery of compliant and efficient commissioning and qualification programs.They will work to establish strong partnerships for efficient deployment of C&Q capability and resources across all geographies.The Global C&Q Director will drive towards best-in-class practices leveraging digital and AI to continuously improve and drive superior performance within commissioning and qualification of large capital projects.ResponsibilitiesLeadership and StrategySupport the development and implement global C&Q strategies, policies, and procedures based on company standards and prevailing regulations.Provide leadership and direction to regional/project C&Q teams to ensure consistent application of standards and practices.Collaborate with senior management to align C&Q activities with business objectives and regulatory requirements.Project ManagementOversee the planning, execution, and completion of C&Q projects across multiple projects.Ensure projects are delivered on time, within budget, and in compliance with regulatory standards.Technical ExpertiseProvide technical guidance and support for C&Q activities, including risk assessments, protocol development, and execution.Quality and ComplianceEnsure that all C&Q activities comply with GSK's quality management system and applicable regulatory requirements (e.g., FDA, EMA, MHRA).Implement continuous improvement initiatives to enhance C&Q processes and outcomes.Team DevelopmentSupport the recruitment, training, and mentoring of C&Q staff to build a high-performing global team.Conduct performance evaluations and provide feedback to support professional growth.Be a global team ambassador to the local site project environment.Act as a visible advocate for diversity in engineering and project delivery.Act as a visible advocate for GSK Safety Life Saving Rules.Stakeholder ManagementBuild and maintain strong relationships with internal and external stakeholders, including suppliers, contractors, and regulatory agencies.QualificationsBasic QualificationsEngineering degree (Mechanical, Electrical, Chemical, Civil/Structural).Extensive project validation experience and proven experience in leading validation teams in pharmaceutical or biotech industry.Proven track record of successfully leading and managing global C&Q projects across all geographies and end-to-end.Proven track record of regulatory authority audit participation and defence of validation project plans and results.In-depth knowledge of regulatory requirements and industry standards (e.g., GMP, GAMP, ICH guidelines).Experience in biopharm specific unit operations and platforms – drug substance/primary, DP/sterile filling, and packaging.Strong project management skills, with experience in managing complex, multi-site projects.Deep and broad understanding of the capital project lifecycle – design, construction, commissioning, qualification, to operation.Strong stakeholder management and influencing capabilitiesLeadership skills that enable the introduction of new ways of working and accelerated change management.Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.Must be comfortable and thrive in ambiguity and think strategically to solve complex problems.Preferred QualificationsMasters in Engineering, Professional Engineer, MBA, CSP, or PMP.Collaboration and participation in industry best-practice guidelines and knowledge sharing groups.Excellent management, communication and interpersonal skills, with comfort cooperating with individuals internally and externally at all organisational levels.Understanding of how different functions interface on GSK projects.Solid knowledge of GSK project process, User requirement management, quality and compliance requirement, site project completion and pre-start processes, and how these impact engineering and design, construction, commissioning, and qualification contracts.Familiar with the GCP Project Management Framework (PMF), relevant engineering standards and compliance requirement as well as Quality Management Systems.Work LocationThis role will preferably be based at any major European or UK-based GSK manufacturing hub on a case-by-case basis and offers a hybrid working model, combining on-site and remote work.Closing Date for Applications7th January ****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.We believe in an agile working culture for all our roles.If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Equal Opportunity EmployerGSK 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.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.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
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