Director, Control Domain Owner
(2-Fixed Term Contract)
GSK HQ (UK), Barnard Castle (UK), Rixensart (Belgium), and Upper Providence (US)
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
ICH M16 Structured Product Quality Submissions (SPQS) will fundamentally change how product quality information is created, governed and exchanged. The Control Domain Owner is accountable for defining and governing the Control data domain, ensuring specifications, analytical procedures, acceptance criteria and related control strategy data are trusted, standardised and fit for future structured regulatory submissions. Working across Research & Development, Global Supply Chain, Quality and Regulatory organisations, the role will define the Control domain strategy, priorities, standards and business requirements required to support Structured Product Quality Submissions (SPQS), Digital Specifications and future regulatory data capabilities. The role will act as the primary business owner for Control domain decisions and will work closely with the SPQS Lead Data Steward, Technology teams and delivery partners to establish scalable, governed Control data products and future digital specifications capabilities.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Define and deliver the strategy, roadmap and governance model for the Control data domain.
- Act as the accountable business owner for Control domain priorities, standards, decisions and risks.
- Work in partnership with business data owners across R&D, Global Supply Chain, Regulatory and Quality to establish aligned Control data standards and practices.
- Define business requirements for Digital Specifications and Methods and future Control data products.
- Drive alignment of Control data across R&D, Quality, Manufacturing, Regulatory and technology platforms.
- Partner with the SPQS Data Steward to embed stewardship requirements, governance processes and data quality controls.
- Establish business rules, definitions and standards supporting structured regulatory data and future SPQS capabilities.
- Partner with Technology teams to support implementation of Control domain capabilities within SAP, LIMS and related platforms.
- Represent GSK in internal and external forums relating to analytical, specification and structured regulatory data initiatives.
- Monitor domain performance and drive continuous improvement activities.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree or equivalent experience in Life Sciences, Pharmaceutical Sciences, Analytical Sciences, Quality, Engineering or a related discipline.
- Significant experience within pharmaceutical development, manufacturing, regulatory, quality or supply chain environments.
- Experience leading complex cross-functional initiatives in large matrix organisations.
- Strong stakeholder management skills with experience influencing senior leaders and subject matter experts.
- Experience defining standards, governance approaches or business processes.
- Ability to make clear business decisions and drive alignment across diverse stakeholder groups.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Experience with specifications, analytical procedures, acceptance criteria, control strategy or quality data.
- Experience supporting ICH, IDMP, or related regulatory data initiatives.
- Experience working with LIMS, LES, Digital Specifications and Methods or related quality systems.
- Experience defining system-of-record strategies, master data capabilities or enterprise data products.
- Participation in industry standards organisations or cross-company data initiatives.
- Experience leading business transformation or digital transformation programmes.
What you will gain
How to apply
8 th
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Uniting science, technology and talent to get ahead of disease together.
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