Director, GPS Quality & Compliance (Biotechnology)

Location: Warren, New Jersey (preferred), Armonk or Tarrytown, New York, or Cambridge, Massachusetts; 4 days per week onsite. Travel: approximately 20%, varying with audit and inspection support needs.

Salary: $183,100–$305,200 annually

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases.

What you will do

• Lead quality event management and inspection readiness workstreams across Global Patient Safety.
• Coordinate and delegate work across teams to ensure consistent program delivery.
• Act as a point of contact during GCP and GVP audits and inspections, supporting preparation and real-time responses.
• Maintain inspection readiness materials and translate regulatory frameworks into practical actions.
• Review quality metrics and trend analyses to provide actionable recommendations to senior leadership.
• Present governance topics and quality insights while coordinating across functions without direct reporting authority.

Requirements

• Bachelor’s degree required; an advanced degree is preferred.
• At least 12 years of pharmaceutical industry experience.
• Deep knowledge of global pharmacovigilance regulations, quality management systems, and inspection readiness frameworks, including FDA CFR and GVP Modules.
• Direct experience facilitating FDA and EMA/MHRA GCP and GVP inspections as an inspection point of contact.
• Experience overseeing QMP governance, metrics programs, and cross-functional quality oversight.
• Experience managing relationships with Global Development Quality, the QPPV Office, Regulatory Affairs, and vendors.

Nice to have

• Healthcare Professional background.
• People management experience.

Culture & Benefits

• Science-driven work focused on developing medicines for serious diseases.
• Inclusive workplace and equal employment opportunity commitment.
• Total rewards may include annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are provided during recruitment where required.