Principal GMP Data Governance Business Partner (Data Integrity)
BioSpace, Limerick, County Limerick, Ireland
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.
Typical Responsibilities
Implementing the Data Governance standards, policies and procedures within allocated areas of the business.
Serving as the key DG contact and providing support and advice to the allocated business unit on DG priorities and action plans.
Assessing current policies and processes of the business unit and coordinating the achievement of local KPIs.
Conducting regular data audits and assessments to identify DG issues and preparing the business unit 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 organization 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 and supporting initiatives to embed DG principles into the company’s core values and everyday practices.
Qualifications
Knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO).
Proven success in implementing and managing policies in regulated environments.
Strong communication and collaboration skills.
Skilled in stakeholder management and influence.
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 an 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.
Benefits
Regeneron is an equal opportunity employer and offers comprehensive benefits 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 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.
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 to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc.
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