Director of R&D Quality-Pharmacovigilance & Medical Affair (Biotech)

Location: Framingham, MA, or Woburn, MA office; remote option available for candidates living beyond 65 miles of the Woburn headquarters, with 10–25% travel to Woburn every 4–6 weeks or as business needs require.

Salary: $209,000–$255,000 annual base pay, plus performance incentive bonus, new-hire equity, and ongoing performance-based equity.

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies through its proprietary RPx platform to transform cancer treatment.

What you will do

• Develop, implement, and maintain quality assurance systems for clinical and commercial pharmacovigilance and medical affairs.
• Translate compliance risks into audit, inspection-readiness, risk-mitigation, and quality oversight strategies.
• Lead vendor quality oversight, quality agreements, governance activities, and external quality management.
• Manage regulatory, sponsor, post-marketing adverse drug experience, and CRO inspections.
• Provide quality oversight for PSMF compliance, REMS development, commercial product safety, non-interventional studies, compassionate use, and medical information.
• Develop training programs and KPI/KQI analyses while driving process improvement across cross-functional teams.

Requirements

• BS or equivalent; an advanced degree is a plus, and a PhD may substitute for three years of experience.
• 10–15 years of progressive pharmacovigilance, medical affairs quality, compliance, or relevant biopharma experience.
• Demonstrated experience in clinical and commercial pharmacovigilance and interaction with medical affairs.
• Extensive knowledge of GCP, GVP, ICH guidelines, and global regulatory requirements.
• Experience leading teams, regulatory inspections, investigations, audits, and interactions with health authorities.
• Strong analytical, problem-solving, communication, organizational, and leadership skills in a matrix environment.

Culture & Benefits

• Mission-driven work focused on developing cancer therapies and improving patient outcomes.
• Values centered on collaboration, boldness, commitment, and candid communication.
• Medical, dental, and vision insurance with a 401(k) match.
• Flexible time off, paid holidays, and a year-end shutdown.