Associate Director, External Supplier QA GMP

Location: Basking Ridge, New Jersey, United States

Salary: USD 153,600–230,400 per year

Company

hirify.global is a global healthcare company developing innovative medicines across oncology, cardiovascular disease, rare diseases, and immune disorders, with operations in more than 30 countries.

What you will do

• Lead quality oversight of contract manufacturing, testing, and warehousing organizations supporting commercial and investigational drug products.
• Ensure supplier quality management systems comply with FDA regulations, global GMP guidelines, internal standards, and inspection requirements.
• Support manufacturing, packaging, labeling, quality control testing, release, and distribution activities for biologic and small-molecule products.
• Review and approve validation, qualification, risk assessment, technical study, and change-control documentation.
• Collaborate with quality, regulatory, pharmaceutical technology, pharmacovigilance, medical affairs, and supply chain stakeholders.
• Support deviation and complaint investigations and develop risk treatments and corrective solutions.

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 or biological operations, including drug manufacturing, packaging, quality assurance, compliance, and audits.
• Experience with biomanufacturing, technical transfer, and contract manufacturing organizations required.
• At least 4 years of direct experience working with multinational drug regulators required.
• Strong understanding of quality management, continuous process improvement, and global cGMP requirements.
• Ability to 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 qualification experience.

Culture & Benefits

• Work within a global organization focused on improving patient lives through innovative medicines.
• Collaborate with affiliates, headquarters, operating sites, and cross-functional global teams.
• Participate in quality improvement and regulatory readiness initiatives across global products.