GMP Data Governance Lead

Location: Troy, New York, United States; onsite, Monday–Friday, 8:00am–4:30pm

Salary: $92,200–$176,000 annually

Company

hirify.global develops life-changing medicines for people with serious diseases through science and innovation.

What you will do

• Lead and manage the Engagement, Culture & Monitoring specialists.
• Drive stakeholder engagement and promote a mature data governance culture across sites.
• Design and deliver continuous data governance training, workshops, seminars, and e-learning programs.
• Translate regulatory and technical requirements into practical guidance for cross-functional teams.
• Collect site data governance KPIs and report findings to Data Governance Business Partners.
• Establish monitoring and auditing processes and collaborate on continuous improvement of the data governance approach.

Requirements

• BA/BS degree and experience in pharmaceutical or FDA-regulated data management, operations, quality assurance, compliance, manufacturing, quality control, or IT.
• 8+ years of relevant experience for Principal Specialist or 10+ years for Staff Specialist; level depends on experience.
• Demonstrated success designing, implementing, and managing training programs for diverse audiences.
• Experience with training management systems and e-learning tools such as LMS and Articulate.
• Strong analytical, communication, stakeholder management, influencing, collaboration, and attention-to-detail skills.
• Knowledge of FDA, EMA, and WHO data integrity guidance, applicable regulations including GDPR, and cGMP/GDP.

Culture & Benefits

• Science-driven organization focused on developing medicines for serious diseases.
• Inclusive workplace with equal opportunity and reasonable accommodation during recruitment where required.
• Competitive total rewards package that may include bonuses, equity awards, retirement benefits, 401(k) match, health and wellness programs, insurance, paid time off, and family support benefits.
• Background checks may verify identity, right to work, and educational qualifications where legally permitted.