GMP Data Governance Lead
Regeneron
August 22, 2026
On-site
Troy, NY
Operations
Discover Your Role
- Lead and manage the Engagement, Culture & Monitoring (ECM) specialists team.
- Drive successful stakeholder engagement and management across sites.
- Promote a mature Data Governance culture with the Global DG (Policy & Programs) Team by designing and delivering continuous DG training aligned to evolving DG knowledge, skills, and awareness needs.
- Design and develop DG training programs focused on DG, regulatory compliance, and best practices for bio-pharmaceutical manufacturing.
- Conduct and facilitate DG training sessions, workshops, and seminars for staff at various organizational levels.
- Leverage technology to improve training delivery (e-learning platforms, simulation tools, virtual training environments).
- Build awareness by engaging employees to build and role model a mature DG culture.
- Act as a DG advocate with Data Stewards to support required cultural/behavioral changes.
- Gather site DG KPIs and report findings to DG Business Partners.
- Establish ongoing monitoring and auditing processes to sustain DG cultural improvements.
- Collaborate with ECM Experts, Technical DG Experts, and Business Partners for continuous improvement of the DG approach.
This Role Requires
- BA/BS degree plus experience in pharmaceutical/FDA-regulated work areas (data management & operations, QA, compliance, manufacturing operations, QC, or IT):
- Principal Specialist: 8+ years
- Staff Specialist: 10+ years
- Level determined by experience.
- Demonstrated success 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 cross-functionally.
- Ability to translate regulatory/technical requirements into clear guidance.
- Strong stakeholder management and influencing skills.
- Experience in cultural/people change management and organizational development.
- Knowledge of applicable regulations/policies and data integrity guidance (e.g., GDPR, FDA/EMA/WHO Data Integrity guidance).
- Knowledge of cGMP & GDP.
Application instructions
- Apply now.
- Lead and manage the Engagement, Culture & Monitoring (ECM) specialists team.
- Drive successful stakeholder engagement and management across sites.
- Promote a mature Data Governance culture with the Global DG (Policy & Programs) Team by designing and delivering continuous DG training aligned to evolving DG knowledge, skills, and awareness needs.
- Design and develop DG training programs focused on DG, regulatory compliance, and best practices for bio-pharmaceutical manufacturing.
- Conduct and facilitate DG training sessions, workshops, and seminars for staff at various organizational levels.
- Leverage technology to improve training delivery (e-learning platforms, simulation tools, virtual training environments).
- Build awareness by engaging employees to build and role model a mature DG culture.
- Act as a DG advocate with Data Stewards to support required cultural/behavioral changes.
- Gather site DG KPIs and report findings to DG Business Partners.
- Establish ongoing monitoring and auditing processes to sustain DG cultural improvements.
- Collaborate with ECM Experts, Technical DG Experts, and Business Partners for continuous improvement of the DG approach.
This Role Requires
- BA/BS degree plus experience in pharmaceutical/FDA-regulated work areas (data management & operations, QA, compliance, manufacturing operations, QC, or IT):
- Principal Specialist: 8+ years
- Staff Specialist: 10+ years
- Level determined by experience.
- Demonstrated success 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 cross-functionally.
- Ability to translate regulatory/technical requirements into clear guidance.
- Strong stakeholder management and influencing skills.
- Experience in cultural/people change management and organizational development.
- Knowledge of applicable regulations/policies and data integrity guidance (e.g., GDPR, FDA/EMA/WHO Data Integrity guidance).
- Knowledge of cGMP & GDP.
Application instructions
- Apply now.