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 field.
- 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 product, material, substance or manufacturing data.
- Experience supporting ICH, ISO, IDMP or related regulatory data initiatives.
- Experience with SAP PLM or related product lifecycle management platforms.
- Experience defining data products, master data capabilities or enterprise data management approaches.
- Participation in industry standards organisations or cross-company data initiatives.
- Demonstrable track record of delivering organisational change and embedding new ways of working.
Responsibilities
- Define and deliver the strategy, roadmap and governance model for the Description data domain.
- Act as the accountable business owner for Description 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 Description data standards and practices.
- Define business requirements for Description data products and future system-of-record capabilities.
- Drive harmonisation of product, material and related Description data across business functions, systems and organisational boundaries.
- 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 Description domain capabilities within SAP PLM and related platforms.
- Represent the Description Domain in key business, data and industry discussions.
- 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
