Senior Manager/Associate Director, Quality

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, or a related field.
• 7+ years of progressive experience in quality, with at least 3 years in a leadership or people management role within biotech, life sciences, or diagnostics.
• Proven track record of owning design control and product development quality from concept through launch, including DHF management.
• Demonstrated experience managing supplier quality and external manufacturing (CDMO) relationships, including audits, quality agreements, and corrective action programs.
• Deep expertise in quality systems and documentation practices (e.g., DHF, SOPs, change control, CAPA); experience building these systems in an early stage or startup environment strongly preferred.
• Strong command of risk management principles and tools (FMEA, hazard analysis, risk-benefit); able to drive risk decisions at an organizational level.
• Exceptional attention to detail with the ability to balance strategic thinking and hands-on execution in a fast-paced, resource-constrained startup environment.
• Excellent cross-functional leadership and communication skills; able to influence without authority, build quality culture, and represent the quality function at the executive level.

Preferred

• Working knowledge of ISO 13485, FDA 21 CFR Part 820 (QSR/QMSR), and/or GMP, CE IVD, UK, CA, UL frameworks; experience preparing for or navigating regulatory inspections a plus
• Experience scaling quality systems from RUO or early-stage through IVD or regulated product development
• Exposure to instrumentation, software and/or reagent-based products