Associate Director, Investigations Excellence & Inspection Readiness (Biopharma)

Location: 100% onsite in Norwood, Massachusetts, United States. Only U.S. persons—citizens, permanent residents, asylees, or refugees—are eligible due to U.S. export control requirements.

Salary: $142,500–$256,500 per year, plus potential bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA technology, medicines, and supporting infrastructure for biopharmaceutical innovation.

What you will do

• Own and continuously improve the quality, rigor, consistency, and effectiveness of site investigations.
• Lead complex cross-functional investigations, systemic problem solving, and CAPA effectiveness programs.
• Partner with manufacturing, logistics, quality, digital operations, and strategy functions to improve reliability and prevent recurrence.
• Establish governance reviews covering investigations, CAPA effectiveness, recurrence reduction, operational risk, and management system health.
• Lead the continuous GMP inspection readiness program using regulatory intelligence, site risks, readiness assessments, simulations, and coaching.
• Build and lead a high-performing team of investigators, problem solvers, trusted advisors, and change agents.

Requirements

• Bachelor’s degree in a technical discipline.
• 10+ years of experience in biopharmaceutical, manufacturing, quality, technical operations, or operational excellence environments.
• Experience leading investigations, CAPA, root cause analysis, or operational improvement programs in a GMP environment.
• Experience with GMP inspection readiness; direct inspection experience is preferred.
• Strong understanding of manufacturing operations, quality systems, continuous improvement, leadership, stakeholder influence, and change management.
• Must be eligible as a U.S. person to access export-controlled information; non-U.S. persons cannot be sponsored for an export control license.

Nice to have

• Direct regulatory inspection experience.

Culture & Benefits

• In-person, site-based working model with direct collaboration and mentorship.
• Competitive healthcare and voluntary benefit programs.
• Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.