Associate Director, BioPharma Partner Audit Excellence (Biopharma)

Location: USA, with preferred hubs in Boston, MA, Washington, DC, or Chicago, IL; remote work from home may be considered

Annual salary: $165,000–$185,000, plus bonus or incentive pay

Company

hirify.global develops diagnostics and biotechnology solutions through its operating companies and partnerships with academic institutions and biopharma organizations.

What you will do

• Coordinate BioPharma partner audits and quality diligence activities across diagnostics operating companies, sites, and delivery models.
• Lead the complete audit lifecycle, including planning, scope definition, execution, issue resolution, and closure of findings.
• Develop standardized audit playbooks, readiness assessments, evidence repositories, communication protocols, and response templates.
• Partner with Quality, Legal, Regulatory, Privacy, Information Security, R&D, Clinical, Operations, Finance, and commercial stakeholders.
• Identify, address, and escalate diligence risks that could affect agreements or partner commitments.
• Improve audit governance, performance measurement, partner experience, and scalable audit practices using hirify.global Business System problem-solving.

Requirements

• Bachelor’s degree in life sciences, quality, engineering, pharmacy, regulatory affairs, or a related field.
• Typically 8+ years of progressive experience in quality, supplier or customer audits, quality systems, compliance, clinical or laboratory operations, regulatory affairs, due diligence, or cross-functional program leadership.
• Working knowledge of regulated quality systems and audit practices relevant to diagnostics, laboratory services, clinical research, software or data-enabled solutions, and biopharma programs.
• Experience leading complex, multi-site or cross-business diligence activities and coordinating accurate responses across multiple functions.
• Ability to travel globally approximately 25% of the time to support partner and site audits.

Nice to have

• Advanced degree or relevant quality certification.
• Experience in diagnostics, medical devices, biopharma, biotechnology, CROs, or another regulated industry.

Culture & Benefits

• Flexible remote working arrangements are available for eligible roles.
• Paid time off and medical, dental, and vision insurance.
• 401(k) benefits for eligible employees.
• Continuous improvement through the hirify.global Business System.