Manager Quality Assurance, Compliance (Biotechnology)

Location: Rensselaer, New York, United States. Onsite role with Monday–Friday hours from 8:00 a.m. to 4:30 p.m.; full cleanroom attire is required.

Salary: $92,200–$176,000 annually.

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Lead and develop the QA compliance, audit, training, and operations team for an internal fill-finish site.
• Set objectives, assign work, coach performance, and manage hiring and separations.
• Report compliance status, audit readiness, and training initiatives to managers and directors.
• Oversee quality records, including Notices of Event, Change Controls, and CAPAs, and drive timely closure.
• Plan and support internal and regulatory audits, including the audit-ready-365 program.
• Identify cross-site improvement opportunities and align policies and processes with industry standards.

Requirements

• BS/BA in Life Sciences or a related field, or an equivalent combination of education and experience.
• 7+ years of relevant experience for the Manager level; level may be determined based on experience.
• Experience with drug product manufacturing and/or fill-finish operations.
• Ability to work onsite in Rensselaer, New York, United States.
• Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments during gowning.

Culture & Benefits

• Science-driven work focused on developing medicines for patients with serious diseases.
• Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace and equal employment opportunity commitment.
• Reasonable accommodation is available during the recruitment process where required.