Job Description:
As a bridge between global policy and standard setting, you will play a fundamental role in safeguarding the quality and reliability of our organisation's data. This is essential for informed decision making and regulatory compliance.
Key Responsibilities:
* Build, lead and manage the site Data Operations & Engagement, Culture & Monitoring (ECM) team to ensure successful delivery of site data governance responsibilities and standards.
* Establish a successful relationship with the global Governance Team (Policies & Programs) to create a clear feedback loop.
* Develop and deliver DG training programs in consultation with Global Data Governance Senior Leadership Team.
* Lead cultural and people change management efforts related to DG, ensuring smooth adoption of new processes, systems and ways of working within the relevant site.
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.
* 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.
Education and Experience:
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.