Director GMP Data Governance

3 weeks ago

Ennis, Ireland Regeneron Pharmaceuticals, Inc Full time

In this role you will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s). Your role will play a fundamental part in safeguarding the quality and reliability of the organisation’s data which is essential for informed decision making and regulatory compliance.

In this role, a typical day might include the following:

1. Successful building, leading and managing of the site Data Operations & Engagement, Culture & Monitoring (ECM) team.
2. Successful delivery/implementation of site data governance (DG) responsibilities and standards.
3. Responsible for successful stakeholder engagement and management across the site.
4. Responsible for establishing a successful relationship with the global Governance Team (Policies & Programs) so a clear feedback loop is established.
5. Responsible for the creation and delivery of DG training programs in consultation with Global Data Governance Senior Leadership Team.
6. Ensuring the team is appropriately resourced, supported and has the tools and direction to properly execute their function.
7. Leading cultural and people change management efforts related to DG ensuring smooth adoption of new processes, systems and ways of working within the relevant site.
8. Responsible with and through the ECM Specialists for developing and embedding DG culture across all elements of IOPS site work.
9. Responsible with and through DG Business Partners for the successful delivery of global standards, policies and procedures at site level and the monitoring of adherence to these standards.
10. Fostering a culture of quality and DG within the organisation and promoting the importance of DG across all departments.
11. Driving communication and collaboration between stakeholders to ensure effective DG practices.
12. Leading/supporting initiatives to embed DG principles into the company’s core values and everyday practices.

This role may be for you if you have:

1. Technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills.
2. Experience in implementing DG policies and initiatives within business units in a regulated environment.
3. Experience in cultural/people change management and driving cultural change related to DG.
4. Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
5. Strong understanding of data governance principles, regulatory requirements and industry standards and the practical application of these in business operations.
6. Extensive experience demonstrating ability to partner, influence and incorporate new standards.
7. Strong people management and team leadership experience.
8. Experience of managing and implementing training programs and monitoring KPI achievement.
9. Strong stakeholder management and influencing skills.
10. The ability to adapt in the face of changing business needs.

To be considered for this role you must hold a BA/BS degree and 12+ years of professional experience or equivalent combination of education and experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

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