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About the Role

Regeneron is seeking a GMP Data Governance & Engagement Lead to foster a culture of data governance within the site by ensuring compliance with Data Governance policies, designing and delivering relevant training, and monitoring Data Governance practices. This role contributes to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Leading and managing the team of Engagement, Culture & Monitoring (ECM) specialists.
• Driving successful stakeholder engagement and management across the sites.
• Promoting a mature Data Governance culture through working in conjunction with the Global DG (Policy & Programs) Team to design & deliver continuous DG Training in line with current and evolving required DG knowledge, skills, and awareness needs.
• Designing and developing comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
• Conducting and facilitating Data Governance focused training sessions, workshops, and seminars for staff at various levels within the organisation.
• Leveraging technology to improve training delivery, including e-learning platforms, simulation tools, and virtual training environments.
• Building awareness through engagement with employees of the need for and the desire to build & role model a mature Data Governance culture.
• Acting as Data Governance advocates with Data Stewards on the culture & behavioural changes required, why, and steps that can be taken to develop an open & transparent DG culture.
• Gathering agreed site Data Governance KPIs and reporting their findings to the DG Business Partners.
• Establishing ongoing monitoring and auditing processes to ensure Data Governance cultural improvements are sustained.
• Collaborating with other ECM Experts, Technical DG Experts & Business Partners to deliver on the plan and feedback themes to allow Continuous Improvement & evolution of the Data Governance approach.

Requirements

• Demonstrated success in designing, implementing, and managing training programs for diverse audiences.
• Experience with training management systems and e-learning tools (e.g., LMS, Articulate).
• Strong analytical skills and attention to detail.
• The ability to collaborate with other ECM Experts, Data Governance Business Partners, Technical Experts and cross-functional teams.
• Ability to translate complex regulatory and technical requirements into clear guidance for cross-functional teams.
• Strong stakeholder management and influencing skills.
• Experience in cultural/people change management and organisational development.
• 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.
• Knowledge of cGMP & GDP.
• BA/BS degree and 8+ years of professional experience (Principal) / 10+ years of professional experience (Staff) 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.

Skills

• Data Governance
• Training Program Design
• Stakeholder Engagement
• cGMP
• GDP
• Data Integrity
• Change Management
• Organizational Development
• E-learning Platforms
• LMS
• Articulate

Location

• Limerick

Work Type

• Onsite

Experience Level

• 8+ years of professional experience (Principal)
• 10+ years of professional experience (Staff)

Education Level

• BA/BS degree

Benefits

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

About the Company

• Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
• Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
• Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
• Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Opportunity

• 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.