Director CMC Quality Compliance (Biotech)

Location: Boston, MA, United States. Hybrid work is available remotely up to two days per week, or the role may be performed on-site five days per week with ad hoc flexibility. Travel of 5–10% may be required.

Salary: $184,600–$277,000 base salary per year, plus eligibility for an annual bonus and annual equity awards.

Company

hirify.global is a global biotechnology company focused on scientific innovation and developing better outcomes for patients.

What you will do

• Lead inspection readiness, inspection management, and compliance programs across GMP areas, including internal manufacturing and testing sites and external CMOs.
• Monitor global cGMP regulatory requirements and trends and incorporate them into phase-appropriate, risk-based control strategies.
• Evaluate compliance risks with cross-functional teams and implement action plans to improve site compliance and quality culture.
• Monitor the inspection readiness and management system, manage escalations, and report through established governance structures.
• Scale inspection and quality programs and integrate new modalities into quality systems as operations expand.
• Provide strategic leadership, coaching, development, and change direction to quality staff.

Requirements

• Bachelor’s degree in a scientific or allied health field, or an equivalent degree.
• Typically 10 years of work experience and 3 years of management experience, or an equivalent combination of education and experience.
• Expert knowledge of global GMP requirements and experience across multiple GxP areas.
• Strong technical knowledge of GMP regulations, inspection management, risk management, and quality governance.
• Ability to make risk-based quality decisions and influence compliance and quality culture.
• Strong facilitation, communication, coaching, and team leadership skills.

Culture & Benefits

• Continuous learning and encouragement to stay informed about AI, technology, automation, and industry trends.
• Medical, dental, and vision benefits, paid time off, and company shutdowns during the summer and winter.
• Educational assistance programs, including student loan repayment.
• Commuting subsidy, matching charitable donations, and 401(k).
• Inclusive workplace with reasonable accommodations and equal employment opportunity commitments.