Director, Control Domain Owner

GSK•Upper Providence, PA

1d•€115,500 - €192,500•Hybrid

About The Position

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, 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.

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 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.
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.