Director QA Operations (Biologics)

Location: Rensselaer, New York, United States. Work model: onsite, Monday–Friday, 8:00am–4:30pm.

Salary: $172,200–$286,900 annually.

Company

hirify.global develops life-changing medicines for people with serious diseases using science and innovation.

What you will do

• Lead quality assurance oversight for drug substance manufacturing operations, including cell culture, centrifugation, chromatography, UFDF, viral clearance, and aseptic dispensing.
• Build departmental strategy, set objectives, and manage a high-performing QA team across manufacturing sites.
• Oversee quality activities on the manufacturing floor, including in-process testing, line clearance, batch record review, product quality response, and holds.
• Lead cross-functional projects, manage internal and external resources, and report milestones and needs to senior management.
• Review and approve deviations, quality events, protocols, reports, change documentation, SOPs, and master batch records.
• Drive CAPA tracking, quality metrics, process improvements, audit readiness, and regulatory inspection activities.

Requirements

• Bachelor’s degree in Life Sciences or a related field, or an equivalent combination of education and experience.
• Minimum 12 years of experience in Quality Operations, Quality Management, or manufacturing.
• Experience in a late-stage or early-stage drug substance or biologics company.
• Experience leading teams, influencing cross-functional stakeholders, and managing quality and compliance issues.
• Ability to work onsite in Rensselaer, New York, Monday–Friday, 8:00am–4:30pm.

Culture & Benefits

• Onsite work environment with a focus on collaboration and inspection readiness.
• Potential benefits include annual bonuses or incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace and equal employment opportunity commitment.