Associate Director, GVP Compliance

Location: Working from home

Company

hirify.global is a biotechnology company developing therapies for rare genetic diseases and operating global pharmaceutical manufacturing and quality organizations.

What you will do

• Advise internal and external stakeholders on Good Pharmacovigilance Practices and regulatory compliance.
• Identify, communicate, and mitigate compliance risks in partnership with business stakeholders.
• Execute GVP audits and support the Global GVP Audit Program.
• Participate in regulatory inspection teams and mock inspection-readiness activities.
• Contribute to Pharmacovigilance System Master File updates and the REMS compliance program.
• Mentor junior staff and support a culture of teamwork and continuous improvement.

Requirements

• 8+ years of experience in a regulated healthcare industry, including quality and compliance responsibilities.
• Experience in pharmacovigilance quality and compliance, health authority inspections, R&D audits, and GVP audit programs.
• Working knowledge of FDA, EMA, global pharmacovigilance, GVP, ICH, and GCP regulations.
• Experience with quality management systems and Microsoft tools.
• Strong strategic thinking, communication, prioritization, decision-making, and presentation skills.
• Bachelor’s degree in a life science field.

Nice to have

• Master’s degree.
• Experience with business development partnerships, mergers, or acquisitions.
• Knowledge of risk management, risk minimization, signal management, case processing, or REMS compliance.

Culture & Benefits

• Global, team-based environment with flexible and empowered colleagues.
• Opportunity to support patient safety and compliance across rare disease pharmaceutical programs.
• Travel may be required for up to 25% or more of the time.