Data Governance Leader for Quality and Compliance

4 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

At Regeneron, we are committed to delivering high-quality data that drives informed decision-making and regulatory compliance.

Job Overview

We are seeking a Data Governance Leader to play a crucial role in safeguarding the quality and reliability of our organization's data.

This individual will act as a bridge between global policy and standard setting and the local implementation of these within the site business unit(s).

The successful candidate will be responsible for:

  • Safeguarding the quality and reliability of our organization's data
  • Implementing site data governance responsibilities and standards
  • Establishing a successful relationship with the global Governance Team (Policies & Programs)
  • Developing and embedding data governance culture across all elements of IOPS site work
  • Monitoring adherence to global standards, policies, and procedures at site level

This role may be suitable for an individual with technical knowledge within the biotech or pharmaceutical sector, coupled with strong relationship building and analytical thinking skills.

The ideal candidate will have experience in implementing data governance policies and initiatives within business units in a regulated environment, as well as cultural/people change management and driving cultural change related to data governance.

They should also possess 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.

Key Responsibilities

The successful candidate will be responsible for:

  • Managing and implementing training programs
  • Monitoring KPI achievement
  • Stakeholder management and influencing skills
  • Ability to adapt in the face of changing business needs

Requirements include a BA/BS degree and 12+ years of professional experience in one of the following pharmaceutical/FDA regulated work areas: data management, quality assurance, compliance, manufacturing operations, technical operations, or IT.

We offer a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Regeneron is an equal opportunity employer and welcomes applications from diverse candidates. We provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment.


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