Job Purpose
Work as Site MSAT Head with responsibility for all manufacturing science and technology
aspects of the Product Lifecycle on site, and a focus on performance, delivery, capability,
behavioral development and talent management to enable the site to meet its business goals.
Education, Experience & Skills
- Graduation/Professional degree in Sciences (Pharmacy, Chemistry etc.)
- 5-7 years’ experience in operations, laboratory or similar functions with understanding of
- Excellent organizational skills with demonstrated Project Management skills and experience, particularly on major technical and/or capital projects
- Thorough knowledge of GMP and Regulatory requirements
- Ability to communicate and influence effectively at all levels in the organization
Key Responsibilities
- Ownership of the core technical business processes for site: Product Lifecycle Management Technical Risk Assessment, Product Control Strategies, Continued Process Verification, Process Robustness Assessment), Process and Cleaning Validation, New Product Introduction and Technical Transfer to other GMS sites/third party manufacturers, Change Control and Risk Management.
- Matrix leadership across Technical, Engineering, Operations, Quality, Packaging & Logistics to support product control strategy translation to shop floor (batch instructions, standard work etc), utilizing the principles of the GSK Production System (GPS).
- Technical governance across Product Lifecycle; Product Performance at Site, Regional and GMS Quality Councils, Technical Review Board, Product Technical Review Team, Capital Expenditure, EHS, Site Impact Assessment and Change Control.
- Provide technical leadership for the rapid resolution of technical issues impacting supply through and product performance investigations through use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA), and escalate key site technical issues to the wider GMS technical community for timely resolution.
- Accountable for on time and right first-time delivery of technical aspects of NPI and Value Engineering projects
- Responsible for dose platform ownership and new technology industrialization (with Engineering) Delivery of key process improvement/optimization projects that contribute to key site metrics; Cost of Goods, Process Robustness, Cost of Poor Quality, yield and waste- process and testing to improve competitiveness and support the commercial ambition.
- Development of business growth opportunities by establishing strong links with Commercial, Category & R&D teams and assuring technical considerations are a core component of network and category strategies.
- Responsible for the commercialization of new products from R&D, and subsequent transfers to other sites. Key focus on project & risk management, technical due diligence and embedding quality and capability to ensure robust, cost-effective manufacturing processes are developed and implemented.
- Proactive Talent Management, including succession planning and capability build within the technical team and active support of the GMS graduate programme and GMS Industrial Placement Programme.
- Responsible for knowledge management of products throughout their lifecycle including validation (PPQ and cleaning validation)
- Manage a budget of approximately £Xm revenue and provide technical support to site capital spend of circa £Xm
- Provides leadership and/or expert input and measurement data into the Material Risk Assessment (MRA) process for AL3/AL2 material changes.
- Work with Quality to ensure all new material suppliers and third party contractors are approved for supply ensuring the specifications and analytical methodologies relating to new products are in place and appropriately used.
- Lead the Data Analysis Task group ensuring that site / regional / functional requirements are
- represented and that best practices are incorporated into the local ways of working.
- Provide a statistical service to a site ensuring that work is completed in accordance with regulatory and internal guidance
- Ensure that Site Safety and Quality Compliance are championed as part of Leadership team
- Responsible for governing risk management process, training of risk advocates and ensuring proper mitigation of safety, quality and business risk at site.
- Proven capabilities in enabling and driving change, delivering solutions, developing people and building relationships across multiple interfaces and in a matrix environment
- Ability to use and interpret data to drive decision making at both tactical and strategic level
- Detailed understanding of Quality by Design and risk management approaches, including FMEA, RCA and technical risks assessments In depth understanding of pharmaceutical/product development Thorough operational knowledge of manufacturing unit operations and plant/laboratory equipment
- Experience in Operational Excellence tools, and use of process performance metrics
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
You may apply for this position online by selecting the Apply now button.
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