Director, Control Domain Owner
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- annual bonus
- eligibility to participate in our share based long term incentive program
- flexible working culture
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What This Job Offers
Job Type
Full-time
Career Level
Director
