Job Summary
Regeneron Ireland DAC is seeking a highly skilled Data Governance (DG) professional to join our team. As a key member of the Regeneron Industrial Operations and Product Supply (IOPS) Data Governance and Integrity program, you will be responsible for implementing DG standards, policies, and procedures into business operations.
Main Responsibilities
* Implementing standards, policies, and procedures within allocated areas of the business
* Serving as the key DG contact for allocated business areas, providing support and advice, and engaging with business units on DG priorities and action plans
* Assessing allocated business units' current policies and processes and overseeing the achievement of local DG KPIs
* Conducting regular data audits and assessments to identify DG issues and working with business areas to prepare for DG auditing and inspections
* Working in partnership with other DG Business Partners, Technical DG Experts & ECM Experts to deliver on the DG plan and provide feedback themes for continuous improvement and evolution of the DG approach
* Fostering a culture of quality and DG 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 (CI) by actively seeking feedback and supporting initiatives designed to enhance data quality and governance
* Leading/supporting initiatives to embed DG principles into the company's core values and everyday practices
Requirements
* 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
* Demonstrated success in implementing and managing policies and standards within a regulated environment
* Excellent communication and collaboration skills
* Strong stakeholder management and influencing skills
* Experience in use of quality systems and/or change management
About You
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
* IT
We are 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.