Senior GMP Data Governance & Engagement Specialist

$59,700 - $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 at Regeneron Pharmaceuticals is responsible for fostering a culture of data governance within the organization. This role involves ensuring compliance with data governance policies, delivering training, and monitoring data governance practices to improve data quality and promote data stewardship. The specialist will work closely with various teams to embed data governance principles into the company's culture and operations.

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 biopharmaceutical manufacturing.
• Assess industry trends and regulatory updates to adjust training strategies accordingly.
• Support the integration of data governance into recruitment, induction, and people development processes.
• Act as a data governance advocate with Data Stewards to promote cultural and behavioral changes.
• Capture and report site data governance metrics to relevant business partners.
• Establish ongoing monitoring and auditing processes to sustain improvements in data governance culture.
• Collaborate with other experts and business partners to deliver on the data governance plan and provide feedback for continuous improvement.

Requirements

• BA/BS degree
• 5+ years of professional experience in pharmaceutical/FDA regulated areas such as data management, quality assurance, compliance, manufacturing operations, quality control, or IT.
• Experience in cultural/people change management and organizational development.
• Knowledge of federal, state, and local regulations (e.g., GDPR) and FDA Guidance on Data Integrity.
• Understanding of cGMP and GDP.

Nice-to-haves

• Experience with e-learning platforms and virtual training environments.
• Familiarity with data governance tools and methodologies.

Benefits

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