Senior GMP Data Governance & Engagement Specialist

$59,700 - $126,800/Yr

Regeneron Pharmaceuticals

Full-time - Mid Level

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. The role emphasizes data stewardship, improving data quality, and embedding data governance principles into the site culture.

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.
• Assess industry trends and regulatory updates to adjust training strategies accordingly.
• Support the business in embedding 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 agreed site data governance metrics and report findings to the DG Business Partners.
• Establish ongoing monitoring and auditing processes to sustain data governance cultural improvements.
• Collaborate with other ECM Experts, Technical DG Experts, and Business Partners to deliver on the data governance plan.

Requirements

• BA/BS degree and 5+ years of professional experience in pharmaceutical/FDA regulated work 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 applicable federal, state, and local regulations, including GDPR and FDA Guidance on Data Integrity.
• Familiarity with cGMP and GDP.

Nice-to-haves

• Experience in developing e-learning platforms and virtual training environments.
• Strong communication and collaboration skills to engage stakeholders effectively.
• Ability to lead initiatives that embed data governance principles into core values.

Benefits

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