Role Overview
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.
* Deliver and implement site data governance (DG) responsibilities and standards successfully.
* Manage stakeholder engagement and management across the site effectively.
* Ensure the team is appropriately resourced, supported and has the tools and direction to properly execute their function.
* Lead cultural and people change management efforts related to DG ensuring smooth adoption of new processes, systems and ways of working within the relevant site.
* Foster a culture of quality and DG within the organisation and promote the importance of DG across all departments.
* Drive communication and collaboration between stakeholders to ensure effective DG practices.
* Lead/support initiatives to embed DG principles into the company's core values and everyday practices.
Requirements
* Hold a BA/BS degree.
* Have 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.
* Have technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills.
* Experience in implementing DG policies and initiatives within business units in a regulated environment.
* Experience in cultural/people change management and driving cultural change related to DG.
* 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.
* Strong understanding of data governance principles, regulatory requirements and industry standards and the practical application of these in business operations.
* Extensive experience demonstrating ability to partner, influence and incorporate new standards.
* Strong people management and team leadership experience.
* Experience of managing and implementing training programs and monitoring KPI achievement.
* Strong stakeholder management and influencing skills.
* Ability to adapt in the face of changing business needs.