Manager, Quality Control

Location: Bridgewater, New Jersey, United States; full-time, in-person presence required. Occasional domestic travel of approximately 10% is required.

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.

What you will do

• Manage and provide technical oversight of QC testing performed by contract laboratories for drug substances and drug products, with an emphasis on inhalation dosage forms.
• Lead analytical projects from initiation through completion, ensuring alignment with timelines, quality expectations, and regulatory requirements.
• Review analytical data packages, protocols, test results, reports, Certificates of Analysis, method validation and transfer documents.
• Manage deviations, OOS and OOT investigations, change controls, root cause analyses, and CAPA implementation.
• Support analytical method implementation and troubleshooting for APSD, MMAD, delivered dose, and particle size distribution testing.
• Develop and review product specifications and QC sections of IND and NDA regulatory submissions, and respond to agency inquiries.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific field.
• At least 4 years of Quality Control experience in the biotechnology or pharmaceutical industry.
• Experience with analytical testing of small-molecule or inhalation drug products.
• Strong understanding of cGMP regulations, ICH guidelines, and global compendial standards, including USP, EP, and JP.
• Experience overseeing contract testing laboratories and reviewing analytical data, technical documents, and regulatory submissions.
• Ability to work full-time in person from the Bridgewater, New Jersey office.

Nice to have

• Advanced degree such as an MS.
• Familiarity with combination products.

Culture & Benefits

• Medical, dental, vision, and mental health support, including an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Access to learning programs, LinkedIn Learning, leadership development, mentorship, networking, employee resource groups, and service programs.