New Product Introduction
1 week ago
New Product Introduction (NPI) Operational Readiness Lead (Senior Director) The posting period will end on the 15th of December 2025 Site Name: UK - County Durham - Barnard Castle Posted Date: Dec 1 2025 Business Introduction We 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 Summary You will lead operational readiness for new product introductions across manufacturing and supply teams based at Barnard Castle. Working closely with manufacturing, quality, engineering, supply chain and regulatory colleagues, you will prepare sites for safe, compliant and timely product start up. You will oversee capital investment, technology transfers and site commissioning to ensure equipment, facilities and personnel are qualified and ready for commercial production. We value practical problem solvers who communicate clearly, build collaborative relationships, and drive delivery with purpose. This role offers visible impact, career growth and the chance to help GSK unite science, technology and talent to get ahead of disease together. Key Responsibilities Leadership Accountabilities Provide visible leadership and be accountable for capital investment and site capability-building (facilities and analytical equipment) to enable development, launch and commercialisation of new assets. Shape investment decisions, remove barriers and drive delivery against strategic milestones. Set the vision and lead operational readiness for new product introductions, aligning manufacturing, quality, engineering, supply chain, regulatory functions on and off site in the broader GSK network to deliver safe, compliant and timely start-up. Drive cross-functional commitment to the readiness plan and be accountable for outcomes. Ensure the site is inspection-ready and confident for regulatory reviews and pre-approval inspections, driving a culture of compliance and continuous preparedness and being accountable for inspection outcomes. Lead and drive cross-functional governance, convening senior stakeholders to make aligned decisions at key readiness gates and to resolve strategic trade-offs that impact timelines or product quality. Define, prioritise and be accountable for readiness initiatives and risk mitigation actions; allocate resources and empower teams to close gaps while intervening decisively and driving resolution when escalation is needed. Champion and drive capability development, ensuring workforce competence through targeted development plans, role clarity and on-the-job coaching so individuals and teams can sustain NPI activities. Be accountable for capability outcomes. Drive site commissioning, qualification and process validation programs, ensuring equipment, facilities and people meet commercial production standards and acceptance criteria. Translate operational readiness requirements into clear scope, timelines and acceptance criteria for handover to operations; be accountable for the end-to-end readiness outcome for assigned products and sites. Act as the senior escalation point with Global stakeholders and be accountable for resolving product- or process-related issues, assessing their enterprise impact. Foster cross-site collaboration and drive adoption of best practice across GSK NPI sites; create and lead a community of practice to continuously improve NPI capability and reproducibility and be accountable for cross-site learning outcomes. Partner with Quality and Regulatory Affairs to shape responses to regulatory questions and to drive a proactive inspection readiness agenda; be accountable for operational evidence and readiness. Align and drive Supply Chain, Procurement and Logistics with launch priorities to secure materials, components and packaging; resolve supply constraints that threaten start-up execution and be accountable for material readiness. Lead and drive development of resilient supply continuity plans and oversee mitigation strategies for potential manufacturing disruptions; be accountable for supply risk outcomes. Use readiness metrics to drive leadership focus, track progress and ensure corrective actions are taken to protect timelines and product quality; be accountable for reported readiness status. Sponsor, drive and be accountable for process optimisation initiatives that deliver step-change in yield, efficiency and cost-effectiveness; ensure improvements are embedded sustainably. Define KPIs that reflect business-critical readiness outcomes (e.g., launch-on-time, Right First Time) and use them to drive accountability, hold teams to account and celebrate delivery. Promote and drive a learning culture: capture lessons from introductions, translate them into improvements, and ensure these are adopted across sites; be accountable for continuous improvement adoption. Basic Qualifications Degree in science, engineering, pharmacy, manufacturing, supply chain or related field. At least 5 years' experience in new product introduction, operational readiness, manufacturing or process transfer in the pharmaceutical or life sciences sector. Practical understanding of GMP requirements and quality systems. Experience working across multi-disciplinary teams and managing stakeholders. Strong planning and project management skills, with experience tracking milestones and risks. Excellent written and verbal communication skills in English. Preferred Qualifications Experience with site commissioning, qualification and validation activities. Background in biologics or sterile manufacturing operations. Formal project management or continuous improvement qualification (for example PRINCE2, PMP, Lean Six Sigma). Experience working with regulatory submissions and readiness evidence. Proven ability to influence senior stakeholders and drive cross-functional decisions. Experience using electronic quality or batch record systems. Working Pattern This role is hybrid, with regular on-site presence required to support sites in the United Kingdom. You will work closely with local site teams and global partners. What we offer You will join a team that values inclusion, active listening and development. You will gain broad exposure across functions and the network. You will make a meaningful contribution to bringing new products into safe and reliable supply, helping patients and communities. If you want to grow your career while making a clear impact, we encourage you to apply. Why GSK? Uniting science, technology and talent to get ahead of disease together. 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 (including family medical history), military service or any basis prohibited under federal, state or local law. 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. For adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click link and scroll to the Careers Section where you will find answers to multiple questions we receive. Important notice to Employment businesses/ Agencies: GSK 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 https://openpaymentsdata.cms.gov/. #J-18808-Ljbffr
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