GMP Data Governance Lead

About the role

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

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 by working 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 Data Governance, regulatory compliance, and best practices for bio-pharmaceutical manufacturing
• Conduct and facilitate Data Governance-focused training sessions, workshops, and seminars for staff at various organizational levels
• Leverage technology to improve training delivery, including e-learning platforms, simulation tools, and virtual training environments
• Build awareness of the need for and benefits of a mature Data Governance culture among employees
• Act as a Data Governance advocate with Data Stewards on required culture and behavioral changes, explaining why and how to develop an open and transparent DG culture
• Gather agreed site Data Governance KPIs and report findings to Data Governance Business Partners
• Establish ongoing monitoring and auditing processes to ensure sustained Data Governance cultural improvements
• Collaborate with other ECM Experts, Technical DG Experts, and Business Partners to deliver on the plan and provide feedback themes for continuous improvement and evolution of the Data Governance approach

Requirements

• Bachelor’s degree in a relevant field
• Principal Specialist: 8+ years of 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
• Staff Specialist: 10+ years of 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
• Level will be determined based on experience
• 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 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 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

Pay

Salary range (annually): $92,200.00 – $176,000.00

Schedule

Location: Troy, NY
Work schedule: Monday–Friday, 8:00 am – 4:30 pm