Job Description
In this role, you will serve as a vital link between global policy and standard setting and the local implementation of these within the site business unit(s). Your responsibilities will play a critical part in safeguarding the quality and reliability of the organisation's data, essential for informed decision making and regulatory compliance.
Key Responsibilities
* Built, led, and managed the site Data Operations & Engagement, Culture & Monitoring (ECM) team successfully.
* Delivered/implemented site data governance (DG) responsibilities and standards successfully.
* Managed stakeholders effectively across the site.
* Established a strong relationship with the global Governance Team (Policies & Programs), ensuring a clear feedback loop was established.
* Crafted and delivered DG training programs in consultation with Global Data Governance Senior Leadership Team.
* Ensured the team had the necessary resources, support, and tools to execute their function properly.
* Led cultural and people change management efforts related to DG, facilitating smooth adoption of new processes, systems, and ways of working within the relevant site.
* Developed and embedded DG culture across all elements of IOPS site work through ECM Specialists.
* Worked with DG Business Partners to deliver global standards, policies, and procedures at site level and monitored adherence to these standards.
* Fostered a culture of quality and DG within the organisation, promoting its importance across all departments.
* Drove communication and collaboration between stakeholders to ensure effective DG practices.
* Supported 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 implementing DG policies and initiatives within business units in a regulated environment.
* Knowledge of applicable federal, state, and local regulations (e.g. GDPR), rules, policies, and procedures such as 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 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.
Qualifications
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.