This leadership role is fundamental in creating, building & motivating a global Data Governance (DG) team responsible for maintaining compliance with regulatory standards. It offers an opportunity to shape the DG landscape of Regeneron, driving innovation and excellence through data. The role will suit a visionary leader with a passion for data and a track record for driving success. The post-holder will set and implement a strategic vision for Regeneron’s data maturity roadmap including policies & procedures. They will lead the required change management program to enable the creation and embedding of a sustainable data quality culture across the organization. They will also be accountable for the Regeneron Industrial Operations and Product Supply (IOPS) DG program & serve as the global leader and subject matter expert on DG practices.
In this role, a typical day might include the following:
The creation & delivery of IOPS’ DG Program (Strategy, Engagement, Culture & Monitoring & Data Ops Leadership) for current and future sites & partners
Adhering to current & evolving global standards using regulatory guidance & industrial intelligence, & generation of policies and procedures
Senior Leadership Team (SLT) stakeholder engagement & holding the business to account in meeting the standards set
Program Management
Ensuring right to operate DG standards are continuously met
Leading, driving and supporting with and through the business a mature DG culture
Ensuring the DG function is appropriately resourced (internal & contract), supported and has the tools & direction to properly execute their function
Delivering role model behaviors in promoting a DG culture across the organisation
Staying updated on latest industry trends, regulatory changes and enforcement actions within the biopharma industry and assessing the impact of these within IOPS
Fostering a culture of quality & DG within the organisation
Promoting the importance of DG across all departments
Driving communication and collaboration between stakeholders to ensure effective DG practices
Encouraging 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
This role may be for you if you have:
Experience demonstrating the ability to partner, influence and incorporate new standards, or extensive experience in changing / revising large-scale program initiatives in the pharmaceutical or biotechnology industry
Recent leadership experience in a data integrity or data governance role
Previous people management and/or team leadership experience
Experience leading cross functional teams and managing enterprise-wide data programs, operating and influencing across a global organization
Significant leading change experience
Experience in integrating cross-corporate processes, information strategies and designing strategic metrics and scorecards
Demonstrated 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
Strong working knowledge of laboratory, manufacturing and support systems, and associated business processes
Experience in a Quality organization (quality systems) and/or Manufacturing operations (Automation)
An understanding and experience in agile methodologies (ex. Lean thinking, Agile methodology, Design thinking, Six sigma, etc.)
To be considered for this role you must hold a BA/BS degree and the following amount of relevant experience for each level:
Sr Director: 15+ years
Executive Director: 20+ years
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 will also be considered. 50% travel required between sites based in Ireland and the USA.
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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.