In this role, you will serve as a crucial link between global policy and standard setting and the local implementation of these within the site business unit(s). Your responsibilities will play a vital part in safeguarding the quality and reliability of the organisation's data, which is essential for informed decision making and regulatory compliance.
Key Responsibilities:
* Lead and manage the site Data Operations & Engagement, Culture & Monitoring (ECM) team successfully.
* Deliver and implement site data governance (DG) responsibilities and standards effectively.
* Engage and manage stakeholders across the site responsibly.
* Establish a successful relationship with the global Governance Team (Policies & Programs) to ensure a clear feedback loop.
* Create and deliver DG training programs in consultation with Global Data Governance Senior Leadership Team.
* Evaluate and ensure the team has adequate resources, support, and tools to execute their functions properly.
* Drive cultural and people change management efforts related to DG, ensuring smooth adoption of new processes, systems, and ways of working within the relevant site.
* Develop and embed DG culture across all elements of IOPS site work with ECM Specialists.
* Work with DG Business Partners to deliver global standards, policies, and procedures at site level and monitor adherence to these standards.
* Foster a culture of quality and DG within the organisation and promote its importance across all departments.
* Promote effective communication and collaboration between stakeholders to ensure efficient DG practices.
* Lead/support initiatives to embed DG principles into the company's core values and everyday practices.
About You:
* You have technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills.
* You have experience implementing DG policies and initiatives within business units in a regulated environment.
* You have experience in cultural/people change management and driving cultural change related to DG.
* You are familiar with 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.
* You have a strong understanding of data governance principles, regulatory requirements, and industry standards and their practical application in business operations.
* You have extensive experience demonstrating ability to partner, influence, and incorporate new standards.
* You have strong people management and team leadership experience.
* You have experience managing and implementing training programs and monitoring KPI achievement.
* You possess strong stakeholder management and influencing skills.
* You can adapt in the face of changing business needs.
Requirements:
* You must hold a BA/BS degree.
* You must have 12+ years of professional experience or an 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.