Associate Director, External Supplier QA GMP

Location: Basking Ridge, New Jersey, United States; onsite role with travel up to 30% of the time.

Salary: USD 153,600–230,400 per year

Company

hirify.global is a global pharmaceutical company developing innovative therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

What you will do

• Lead external supplier quality assurance activities for pharmaceutical and biological operations.
• Oversee quality, compliance, auditing, manufacturing, and packaging requirements for contract manufacturing organizations.
• Apply global cGMP requirements and quality management principles to supplier operations.
• Support technical transfer and projects involving pharmaceutical or biopharmaceutical manufacturing.
• Engage with multinational drug regulators and drive continuous process improvement.

Requirements

• Bachelor’s degree in a scientific discipline required; a master’s or other advanced degree is preferred.
• At least 7 years of experience in pharmaceutical and/or biological operations, including drug manufacturing, packaging, quality assurance, compliance, and auditing.
• Experience with biomanufacturing and technical transfer required.
• At least 4 years of direct experience working with multinational drug regulators required.
• Experience with contract manufacturing organizations and a solid understanding of global cGMP requirements required.
• Ability to work in Basking Ridge, New Jersey, and travel up to 30% of the time.

Nice to have

• Previous management experience.
• Experience with aseptic or sterile manufacturing.
• Experience in pharmaceutical or biopharmaceutical project environments.
• Cold chain qualifications.

Culture & Benefits

• Work within a global pharmaceutical organization focused on innovative medicines and improving patient outcomes.
• Collaborate across an international company with a presence in more than 30 countries.
• Equal opportunity employment environment.