Senior Manager, Quality Operations (Pharmaceutical Quality Assurance)

Location: Northbridge, United States; in-person role with a hybrid schedule requiring at least three days in the office

Salary: $142,140–$179,220 USD annually

Company

hirify.global is an ophthalmology company developing and commercializing innovative therapeutics focused on preventing blindness.

What you will do

• Lead and develop the site Quality Operations team from process validation through commercial drug product manufacturing.
• Oversee incoming material release, batch record review, QC testing, lot disposition, quality events, APQR reconciliation, and quality oversight at the Northbridge facility.
• Implement and maintain quality systems, policies, and procedures supporting cGMP, FDA, and other regulatory requirements.
• Review and approve SOPs, validation documents, risk assessments, manufacturing records, audit documents, change controls, deviations, and CAPAs.
• Collaborate with Quality, Manufacturing, CMC, Supply Chain, Quality Engineering, and external CMO/CTO partners.
• Lead inspection readiness, participate in mock and regulatory inspections, and serve as Quality Lead on product development teams.

Requirements

• 10+ years of related experience in the pharmaceutical or biotechnology industry, preferably in pharmaceutical development and Quality Assurance Operations.
• Bachelor’s degree in a scientific or technical discipline required; master’s degree is a plus.
• Strong GMP experience covering technical development, manufacturing, validation, and commercialization in an FDA-regulated environment.
• Experience managing Quality Assurance Operations for commercial combination products and overseeing CMO operations.
• Leadership experience managing cross-functional teams, including delegation, resource allocation, talent assessment, recruitment, retention, and employee development.
• Experience with inspection readiness, PAI inspections, auditing or auditor certification, Quality On The Floor processes, and electronic manufacturing systems such as ERP or MES.

Culture & Benefits

• Hybrid work schedule with regular in-person collaboration at the Northbridge facility.
• Culture centered on transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Work in an ophthalmology organization focused on improving patients’ lives through innovative therapeutics.
• Commitment to equal opportunity, diversity, and inclusion.