Principal GMP Data Governance Business Partner

5 days ago

Limerick, Limerick, Ireland Regeneron Full time

Join to apply for the Senior Data Integrity Lead role at Regeneron

Join to apply for the Senior Data Integrity Lead role at Regeneron

Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program.

In this role, a typical day might include the following:

  • Implementing the Data Governance standards, policies and procedures within allocated areas of the business
  • Being the allocated business area(s) key DG contact providing support and advice and engage with the allocated business unit on DG priorities and action plans
  • Assessing allocated business unit's current policies and processes and coordinate the achievement of local KPIs
  • Conducting regular data audits and assessments to identify DG issues and work with business area to prepare for DG auditing and inspections
  • Working with DG Business Partners, Technical Experts, and ECM Experts to deliver the DG plan and provide feedback for continuous improvement
  • Encouraging a culture of quality and Data Governance within the organisation and promoting the importance of DG across all departments
  • Driving communication and collaboration between stakeholders to ensure effective DG practices
  • Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to improve data quality and governance
  • Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices

This Role May Be For You If
  • You have knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO)
  • You have proven success in implementing and managing policies in regulated environments
  • You bring strong communication and collaboration skills
  • You are skilled in stakeholder management and influence
  • You have experience with quality systems and change management

To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as: data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) 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 all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionInformation Technology
  • IndustriesBiotechnology

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