Director, Control Domain Owner

GSK; Greater London; On-site; GBP 150,000 - 190,000; Full time

Job summary

GSK is seeking a Director, Control Domain Owner to lead the governance and strategy for the Control data domain across R&D, Quality, Regulatory and Manufacturing. You will collaborate with SPQS, technology teams and external partners to define standards and scalable data products.

The role focuses on harmonising specifications, analytical methods and control strategy data to support SPQS and future regulatory data capabilities.

Qualifications

• Requires a degree in Life Sciences, Pharmaceutical Sciences, Analytical Sciences, Quality, Engineering or related field.
• Significant experience in pharmaceutical development, analytical sciences, quality, manufacturing or regulatory environments.
• Experience defining and implementing governance frameworks or data management capabilities.

Responsibilities

• Own the Control domain roadmap, priorities and business outcomes.
• Define and approve standards, definitions and rules for Control data.
• Act as decision owner for domain risks, issues and escalation.
• Define requirements for Digital Specifications and future Control data products.
• Embed stewardship and data quality controls with SPQS Lead Data Steward.
• Drive alignment of Control data across R&D, Quality, Manufacturing and Regulatory.
• Translate evolving regulatory requirements into practical capabilities and standards.
• Support Digital Specifications, Control pilot activities and SPQS deployment.

Skills

Stakeholder skills

Cross-functional leadership

Influencing skills

Strategic roadmapping

Education

Bachelor's degree or equivalent in Life Sciences/Pharma/Engineering

Job description

Director, Control Domain Owner (2-Fixed Term Contract)

Locations - GSK HQ (UK), Barnard Castle (UK), Rixensart (Belgium), and Upper Providence (US)

Reporting to - Executive Director, CMC Data Strategy (SPQS)

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 standards, priorities, decisions and risks.
• Define business requirements for Digital Specifications and Methods and future Control data products.
• Drive harmonisation of specification, analytical method and control strategy data across R&D, Quality, Regulatory and Manufacturing organisations.
• Establish business rules, definitions and standards supporting structured regulatory data and future SPQS capabilities.
• Partner with Technology teams to support implementation of Digital Specifications, Methods and related Control domain capabilities.
• Represent GSK in internal and external forums relating to analytical, specification and structured regulatory data initiatives.

Responsibilities

• Own the Control domain roadmap, priorities and business outcomes.
• Define and approve business standards, definitions and rules governing specifications, analytical procedures, acceptance criteria and related Control data.
• Act as the decision owner for domain risks, issues, trade-offs and escalation activities.
• Define requirements for Digital Specifications, Control data products and future system-of-record capabilities.
• Partner with the SPQS Lead Data Steward to embed stewardship requirements, governance processes and data quality controls.
• Drive alignment of Control data across R&D, Quality, Manufacturing, Regulatory and technology platforms.
• Ensure consistency and traceability between Description data, Control data and future structured submission requirements.
• Translate evolving regulatory requirements into practical business capabilities and domain standards.
• Support delivery of Digital Specifications, Control pilot activities and future SPQS deployment initiatives.
• Monitor domain performance and drive continuous improvement activities.

Why You?

Basic Qualification

• Bachelor's degree or equivalent experience in Life Sciences, Pharmaceutical Sciences, Analytical Sciences, Quality, Engineering or a related discipline.
• Significant experience within pharmaceutical development, analytical sciences, quality, manufacturing or regulatory environments.
• Experience defining and implementing business standards, governance frameworks or data management capabilities.
• Experience leading cross-functional initiatives in large, matrix organisations.
• Strong stakeholder management, facilitation and influencing skills.
• Ability to make clear business decisions and drive alignment across multiple stakeholder groups.