Vice President, Quality Operations (Combination Products)

Location: 100% onsite at the RTP, North Carolina location, ZIP code 27713, United States. Relocation assistance may be available for non-local candidates.

Company

hirify.global is a publicly traded biotechnology and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs.

What you will do

• Lead Quality Operations for dry powder inhaler and soft mist inhaler facilities producing, labeling, and packaging drug products and medical devices.
• Ensure compliance with GMP/GDP, FDA, EU, JP, and other applicable global regulatory requirements.
• Lead facility start-up quality activities, including equipment qualification, process validation, regulatory filings, and Health Authority inspections.
• Oversee GMP documentation, batch records, deviations, validation protocols, regulatory filings, and product disposition.
• Build quality agreements with manufacturing vendors and device suppliers and adapt quality systems for combination products.
• Drive risk assessments, CAPAs, technology transfer, continuous improvement, training, and cross-functional collaboration with Manufacturing, Regulatory Affairs, Engineering, and Supply Chain.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience and training.
• 15+ years of progressively responsible experience in pharmaceutical or fine chemicals quality functions.
• 10+ years of management experience, including 5+ years overseeing both QA and QC functions.
• Experience with FDA, USP, EP, EU, and JP requirements; cGMPs; stability testing; analytical method development and validation; and laboratory method transfer.
• Experience with HPLC, GC, UV/VIS, FTIR, and IQ/OQ/PQ qualification protocols for laboratory and manufacturing equipment.
• Strong organizational, prioritization, communication, and MS Office skills, with the ability to work independently and manage high-pressure workloads.

Nice to have

• Master’s degree in a scientific discipline or equivalent experience and training.

Culture & Benefits

• Mission-driven work focused on unmet medical needs and patient benefit.
• Medical, dental, vision, prescription, wellness, savings plan, 401(k), and ESPP programs.
• Paid time off, paid parental leave, and disability benefits.
• Relocation assistance may be available for non-local candidates.