About This Role
In this critical position, you will serve as a liaison between global policy and standard-setting initiatives and their local implementation within our site's business units.
Your key responsibilities will focus on safeguarding the quality and reliability of our organization's data, which is essential for informed decision-making and regulatory compliance.
A typical day in this role may involve:
* Leading and managing the site Data Operations & Engagement, Culture & Monitoring (ECM) team to ensure successful delivery of site data governance (DG) responsibilities and standards.
* Fostering stakeholder engagement and management across the site to establish a clear feedback loop with the global Governance Team (Policies & Programs).
* Developing and delivering DG training programs in consultation with Global Data Governance Senior Leadership Team.
* Ensuring the ECM team is appropriately resourced, supported, and equipped with the tools and direction to execute their function effectively.
* Driving cultural and people change management efforts related to DG, ensuring smooth adoption of new processes, systems, and ways of working within the relevant site.
This role requires:
* 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 (e.g., GDPR), rules, policies, and procedures such as FDA Guidance on Data Integrity, EMA Data Integrity Guide, and WHO Guide to Data Integrity.
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.