Job Title: Data Operations & Governance Specialist
In this critical role, you will serve as a liaison between global policy and standard setting, and the local implementation of these within our business unit(s). Your responsibilities will play a pivotal part in safeguarding the quality and reliability of our organisation's data, which is essential for informed decision making and regulatory compliance.
Key Responsibilities:
* Build, lead, and manage the site Data Operations & Engagement, Culture & Monitoring (ECM) team with success.
* Deliver and implement site data governance (DG) responsibilities and standards effectively.
* Engage and manage stakeholders across the site successfully.
* Establish a strong 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.
* Ensure the team has the necessary resources, support, tools, and direction to execute their function properly.
* Lead cultural and people change management efforts related to DG to ensure 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 through ECM Specialists.
* Deliver global standards, policies, and procedures at site level with the monitoring of adherence to these standards through DG Business Partners.
* Foster a culture of quality and DG within the organisation and promote its importance 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:
* Tech knowledge within the biotech or pharmaceutical sector combined 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 driving cultural change related to DG.
* Knowledge of applicable federal, state, and local regulations, rules, policies, and procedures (e.g. 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 their practical application in business operations.
* Extensive experience demonstrating ability to partner, influence, and incorporate new standards.
* Strong people management and team leadership experience.
* Experience in 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.
Qualifications:
* Bachelor’s degree required.
* 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.