GMP Data Governance Lead

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 92,200 - 176,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc (USA) seeks a seasoned Data Governance Training Lead in Troy, NY to drive ECM initiatives, design comprehensive DG training, and promote a mature governance culture across sites. The role focuses on regulatory compliance, cGMP standards, and effective use of LMS/e-learning tools.

You will lead workshops, collaborate with data stewards, and track DG KPIs to ensure continuous improvement in governance practices and staff awareness.

Qualifications

• BA/BS degree and experience in pharma/FDA-regulated work areas (data management, quality, IT, operations).
• Experience designing and managing training programs for diverse audiences.
• Experience with LMS and e-learning tools (e.g., Articulate).
• Ability to translate regulatory/technical requirements into clear guidance for cross-functional teams.

Responsibilities

• Lead and manage the Engagement, Culture & Monitoring (ECM) team.
• Drive stakeholder engagement and management across sites.
• Promote mature Data Governance culture with DG Training programs.
• Design and deliver comprehensive DG training on regulations and best practices.
• Facilitate DG-focused training sessions, workshops, and seminars for staff.
• Leverage technology to improve training delivery (e-learning platforms, simulations).
• Build awareness and role-model a mature DG culture among employees.
• Collaborate with Data Stewards and cross-functional teams on DG culture changes.
• Gather DG KPIs and report findings to DG Business Partners.
• Establish monitoring and auditing to sustain improvements.
• Partner with ECM Experts, Technical DG Experts & Business Partners for continuous evolution.

Skills

Data governance

Training design

Stakeholder management

LMS & e-learning tools

Regulatory knowledge

cGMP & GDP

Change management

Analytical skills

Education

BA/BS degree

Tools

LMS

Articulate

Job description

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

Location: Troy, NY

Work schedule: Monday-Friday, 8am-4:30pm

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
• family support benefits

Salary Range (annually) $92,200.00 - $176,000.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.

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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.