GMP Data Governance Lead

BioSpace; City of Troy (NY); On-site; USD 92,000 - 176,000; Full time

Job summary

Regeneron seeks a GMP Data Governance Lead (Principal/Staff) to foster a culture of data governance at the Troy, NY site. You will design and deliver DG training, ensure compliance with data governance policies, and monitor DG practices across the team and site.

You will lead training initiatives, collaborate with Global DG and Business Partners, and drive continuous DG improvements through analytics and stakeholder engagement. This is an onsite role in Troy, NY.

Qualifications

• BA/BS degree in a related field and extensive experience in pharma/FDA regulated environments.
• Experience designing and delivering DG training programs and compliance training.
• Knowledge of GDPR, FDA Data Integrity, EMA Data Integrity, WHO Data Integrity.
• Ability to translate complex regulatory requirements into clear guidance for cross-functional teams.
• Strong stakeholder management and training delivery skills.

Responsibilities

• Lead and manage the ECM team across DG initiatives.
• Design and deliver comprehensive DG training programs and compliance training.
• Promote a mature Data Governance culture at the site in collaboration with Global DG teams.
• Collaborate with ECM Experts, Data Governance partners and cross-functional teams.
• Monitor DG KPIs and report findings to DG Business Partners.
• Establish ongoing monitoring and auditing to sustain DG improvements.
• Leverage e-learning platforms and simulation tools to deliver training.

Skills

Training management

LMS

Articulate

Data governance

Regulatory knowledge

Stakeholder management

Cross-functional collaboration

Change management

Analytical skills

Communication

Education

BA/BS in related field

Tools

LMS

Articulate

Job description

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.

When and where?

• Location: Troy, NY
• Work schedule: Monday-Friday, 8am-4:30pm

Discover Your Role

• 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

This Role Requires

• 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
  • Level will be determined based on experience
• 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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$92,200.00 - $176,000.00