Senior GMP Data Governance Trainer

$77,600 - $126,800/Yr

Regeneron Pharmaceuticals - Troy, NY

Full-time - Mid Level

Troy, NY

Professional, Scientific, and Technical Services

About the position

The Senior GMP Data Governance & Engagement Specialist plays a crucial role in fostering a culture of data governance within the organization. This position is responsible for ensuring compliance with data governance policies, delivering relevant training, and monitoring data governance practices to improve data quality and stewardship. The role involves collaboration with various teams to craft and implement training programs and establish ongoing monitoring processes to sustain cultural improvements in data governance.

Responsibilities

• Craft and deliver continuous data governance training in line with current and evolving knowledge and skills needs.
• Develop comprehensive training programs focused on data governance, compliance with regulations, and best practices for bio-pharmaceutical manufacturing.
• Collect and report site data governance metrics to the DG Business Partners.
• Establish ongoing monitoring and auditing processes to ensure sustained improvements in data governance culture.
• Collaborate with ECM Experts, Technical DG Experts, and Business Partners to execute the data governance plan and provide feedback for continuous improvement.

Requirements

• BA/BS degree in a relevant field.
• 5+ years of professional experience in pharmaceutical/FDA regulated areas such as data management, quality assurance, compliance, or IT.
• Experience in cultural/people change management and organizational development.
• Knowledge of federal, state, and local regulations such as GDPR, FDA Guidance on Data Integrity, and EMA Data Integrity Guide.
• Familiarity with cGMP and GDP.

Nice-to-haves

• Experience with e-learning platforms and virtual training environments.
• Strong communication and collaboration skills to engage stakeholders effectively.
• Ability to drive continuous improvement initiatives.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off