Director, Control Domain Owner

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 150,000 - 210,000; Full time

Job summary

GlaxoSmithKline in Upper Providence, US is seeking a Control Domain Owner for ICH M16 SPQS to define and govern the Control data domain, set standards, and align data across R&D, Global Supply Chain, Regulatory and Quality.

You will partner with SPQS Data Steward and technology teams to implement Control domain capabilities in SAP and LIMS, drive governance, and deliver scalable data products and future digital specifications that support regulatory submissions.

Qualifications

• Bachelor's degree or equivalent in Life Sciences, Pharmaceutical Sciences, Analytical Sciences, Quality, Engineering or 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.

Responsibilities

• 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.

Skills

Data Governance

Data Quality

Data Standards

Master Data

Metadata Standards

Data Security

Incident Management

Education

Bachelor's degree in Life Sciences or related

Tools

SAP

LIMS

Digital Specifications & Methods

Job description

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.

Responsibilities

• 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

• 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

• 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

You will influence high-impact decisions and shape domain practice across GSK. You will work with experienced colleagues who share a clear purpose. You will grow your leadership skills and technical understanding while making work easier and safer for many teams. If you want to help GSK turn robust control design into faster, more reliable outcomes for patients.

Closing date for applications: 8th September 2026 (EOD)

Skills

Data Governance, Data Quality, Data Quality Improvement, 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 [e-mail] where you can also request a call.

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 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. 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.

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, visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Helping all candidates find great careers is our goal. The information you provide here is secure and confidential.

We are now directing you to the original job posting. Please apply directly for this job at the employer’s website.