Leave us your email address and we'll send you all the new jobs according to your preferences.
Director, Control Domain Owner
Posted 5 hours 3 minutes ago by Biopharma Careers
Permanent
Not Specified
Other
London, United Kingdom
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:
Closing date for applications 8th September 2026 (EOD)
Skills
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
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 should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the Link 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 . click apply for full job details
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 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.
- 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.
- 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.
Closing date for applications 8th September 2026 (EOD)
Skills
- Data Governance
- Data Quality
- Data Security
- Data Standards
- Incident Management
- Master Data
- Metadata Standards
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
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 should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the Link 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 . click apply for full job details
Biopharma Careers
Related Jobs
Head of Legal & Business Affairs (FTC)
- London, United Kingdom
Operator Fulltime Area Alphen aan den Rijn
- 3 000,00 € - 3 800,00 € Monthly
- Zuid-Holland, Alphen aan den Rijn, Netherlands, 2401 AA
Legal Counsel
- London, United Kingdom
Audit Senior
- £40,000 Annual
- Lanarkshire, Glasgow, United Kingdom, G32 0
Clerk of Works
- £50,000 Annual
- Yorkshire, Sheffield, United Kingdom, S5 9