**Role Summary**
In this key 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 responsibilities 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.
The successful candidate will have a typical day that includes the following:
* Building, leading and managing of the site Data Operations & Engagement, Culture & Monitoring (ECM) team to ensure its success.
* Delivery/implementation of site data governance (DG) responsibilities and standards, ensuring they are met and maintained.
* Engaging with and managing stakeholders across the site to foster strong relationships.
* Establishing and maintaining a successful relationship with the global Governance Team (Policies & Programs) to ensure clear communication and feedback.
* Creating and delivering DG training programs in consultation with Global Data Governance Senior Leadership Team to educate staff.
* Ensuring the team has the necessary resources, support, and tools to execute their function effectively.
* Leading cultural and people change management efforts related to DG to facilitate smooth adoption of new processes, systems, and ways of working within the site.
* Developing and embedding DG culture across all elements of IOPS site work with ECM Specialists.
* Working with DG Business Partners to deliver global standards, policies, and procedures at site level and monitor adherence to these standards.
* Fostering a culture of quality and DG within the organisation and promoting its importance across all departments.
* Driving communication and collaboration between stakeholders to ensure effective DG practices.
* Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices.
This role may be suited to candidates who 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.
* Cultural/people change management experience and ability to drive cultural change related to DG.
* Knowledge of applicable federal, state, and local regulations, rules, policies, and procedures such as GDPR, 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.
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.