GMP Data Governance Lead

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Join our Quality Assurance team as a GMP Data Governance Lead at the Principal or Staff level and contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

About the role

In this role, you will 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.

Location: Troy, NY
Work schedule: Monday-Friday, 8am-4:30pm

Responsibilities

• Lead and manage the team of Engagement, Culture & Monitoring (ECM) specialists
• Drive successful stakeholder engagement and management across the sites
• Promote a mature Data Governance culture through collaboration with the Global DG (Policy & Programs) Team to design and deliver continuous DG training aligned with current and evolving DG knowledge, skills, and awareness needs
• Design and develop comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing
• Conduct and facilitate Data Governance-focused training sessions, workshops, and seminars for staff at various levels within the organization
• Leverage technology to improve training delivery, including e-learning platforms, simulation tools, and virtual training environments
• Build awareness through engagement with employees on the need for and desire to build and role model a mature Data Governance culture
• Act as Data Governance advocates with Data Stewards on cultural and behavioral changes required, explaining the rationale and steps to develop an open and transparent DG culture
• Gather agreed site Data Governance KPIs and report findings to the DG Business Partners
• Establish ongoing monitoring and auditing processes to ensure Data Governance cultural improvements are sustained
• Collaborate with other ECM Experts, Technical DG Experts, and Business Partners to deliver on the plan and provide feedback for continuous improvement and evolution of the Data Governance approach

Requirements

• BA/BS degree
• Experience in pharmaceutical/FDA regulated work areas such as data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT, or equivalent combination of education and experience:
  • Principal Specialist: 8+ years
  • Staff Specialist: 10+ years
• 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
• Ability to collaborate with 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 organizational 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

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

• 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

Pay

Salary Range (annually): $92,200.00 - $176,000.00

Schedule

Monday-Friday, 8am-4:30pm