Director, Description 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 Description Domain Owner is accountable for defining and governing the Description data domain, ensuring product, material and related CMC description data is trusted, standardised and fit for future structured regulatory submissions. Working across Research & Development, Global Supply Chain, Regulatory and Quality organisations, the role will define the Description domain strategy, priorities, standards and business requirements required to support Structured Product Quality Submissions (SPQS), IDMP and future digital regulatory capabilities. The role will act as the primary business owner for Description domain decisions and will work closely with the SPQS Lead Data Steward, Technology teams and delivery partners to establish scalable, governed Description data products and future system-of-record capabilities.
Requirements
- Bachelor's degree or equivalent experience in Life Sciences, Pharmaceutical Sciences, Data Management or a related discipline.
- Significant experience within pharmaceutical development, manufacturing, regulatory, quality or supply chain 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 CMC product, material, substance or manufacturing data.
- Experience supporting IDMP, SPQS, ISO CMC or related regulatory data initiatives.
- Experience with SAP PLM or related product lifecycle management platforms.
- 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
- Own the Description domain roadmap, priorities and business outcomes.
- Define and approve business standards, definitions and rules governing Description data.
- Act as the decision owner for domain risks, issues, trade-offs and escalation activities.
- Define requirements for Description data products, federated ownership models 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 Description data across business functions, systems and technology platforms.
- Translate evolving regulatory requirements into practical business capabilities and domain standards.
- Support delivery of Description pilot activities and future SPQS deployment initiatives.
- Monitor domain performance and drive continuous improvement activities.
Benefits
- Annual bonus
- Eligibility to participate in our share based long term incentive program
- Flexibility in working arrangements
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What This Job Offers
Job Type
Full-time
Career Level
Director
