GMP Data Governance Lead

Regeneron Pharmaceuticals

1d•$92,200 - $176,000•Onsite

About The Position

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 be responsible for fostering 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.

Requirements

BA/BS degree and the following amount 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, for each level: Principal Specialist: 8+ years, Staff Specialist: 10+ years
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
The 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

Responsibilities

Leading and managing the team of Engagement, Culture & Monitoring (ECM) specialists
Driving successful stakeholder engagement and management across the sites
Promoting a mature Data Governance culture through working in conjunction with the Global DG (Policy & Programs) Team to design & deliver continuous DG Training in line with current and evolving required DG knowledge, skills, and awareness needs
Designing and developing comprehensive training programs focused on DG, compliance with regulations, and best practices for bio-pharmaceutical manufacturing
Conducting and facilitating Data Governance focused training sessions, workshops, and seminars for staff at various levels within the organization
Leveraging technology to improve training delivery, including e-learning platforms, simulation tools, and virtual training environments
Building awareness through engagement with employees of the need for and the desire to build & role model a mature Data Governance culture
Acting as Data Governance advocates with Data Stewards on the culture & behavioral changes required, why, and steps that can be taken to develop an open & transparent DG culture.
Gathering agreed site Data Governance KPIs and reporting their findings to the DG Business Partners
Establishing ongoing monitoring and auditing processes to ensure Data Governance cultural improvements are sustained
Collaborating with other ECM Experts, Technical DG Experts & Business Partners to deliver on the plan and feedback themes to allow Continuous Improvement & evolution of the Data Governance approach