Job Title
In this critical role, you will serve as a vital bridge between global policy and standard setting and the local implementation of these within our business unit(s).
Your primary focus will be on safeguarding the quality and reliability of our organisation's data, which is essential for informed decision making and regulatory compliance.
A typical day in this role might 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.
* Managing stakeholder engagement and communication across the site.
* Establishing a successful relationship with the global Governance Team (Policies & Programs) to ensure a clear feedback loop.
* Creating and delivering DG training programs in consultation with Global Data Governance Senior Leadership Team.
Key Responsibilities
* Ensuring the team is appropriately resourced, supported, and has the tools and direction to properly execute their function.
* 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.
* Developing and embedding DG culture across all elements of IOPS site work, working closely with ECM Specialists.
* Collaborating with DG Business Partners for the successful delivery of global standards, policies, and procedures at site level, and monitoring adherence to these standards.
* Fostering a culture of quality and DG within the organisation, promoting the importance of DG 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.
Requirements
* 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, 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.
* 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.
* The ability to adapt in the face of changing business needs.
Education and Experience
* Bachelor's degree or equivalent combination of education and experience.
* 12+ years of professional experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.