**Global Policy Bridge Role**
In this critical position, you will serve as a vital link between international policy and standard setting, and the local implementation of these standards within our site business unit(s). Your role will play a fundamental part in safeguarding the quality and reliability of our organisation's data, which is essential for informed decision making and regulatory compliance.
The responsibilities of this role include:
* Successfully building, leading, and managing the site Data Operations & Engagement, Culture & Monitoring (ECM) team.
* Delivering and implementing site data governance (DG) responsibilities and standards.
* Engaging with stakeholders across the site and establishing successful relationships with key teams.
* Establishing a clear feedback loop with the global Governance Team (Policies & Programs).
* Creating and delivering DG training programs in consultation with Global Data Governance Senior Leadership Team.
* 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, ensuring 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, in collaboration with ECM Specialists.
* Working with DG Business Partners to deliver global standards, policies, and procedures at site level, and monitoring 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.
* Embedding DG principles into the company's core values and everyday practices.
This role may be suitable for individuals with:
* 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.
* Expertise in cultural/people change management and driving 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.
* A 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.