Director, Quality (Biotech)

Location: Shrewsbury, Massachusetts, United States; facility-based role

Salary: $180,000–$230,000 annually, plus eligibility for variable cash compensation and, for eligible roles, equity.

Company

hirify.global develops technologies and solutions for bioprocessing and supports the production of biologic drugs.

What you will do

• Lead Quality Operations and Incoming Quality Control for the manufacturing operation and distribution center.
• Maintain the ISO 9001 Quality Management System, including audits, CAPA, nonconforming materials, validation, complaints, and change controls.
• Partner with cross-functional and Global Supplier Quality teams to resolve quality issues and drive continuous improvement.
• Author and revise procedures and specifications, and ensure effective training and adoption of quality systems.
• Serve as Management Representative to the ISO 9001 registrar and maintain audit readiness.
• Develop quality metrics, support KPI reporting and management reviews, and lead operational excellence initiatives.

Requirements

• Bachelor’s degree in Engineering, Biology, or Chemistry.
• At least 10 years of experience in a cGMP, ISO 13485, or ISO 9001 Quality Management System environment.
• At least 5–8 years of experience mentoring, developing, and supervising direct reports.
• Strong communication, organizational, influencing, negotiation, facilitation, and problem-solving skills.
• Demonstrated ability to build a quality culture and develop high-performing quality teams.

Nice to have

• ASQ CQA and/or CQE certification.
• Experience with LEAN implementation.

Culture & Benefits

• Leadership expectations emphasize integrity and compliance, customer focus, collaboration, courage, team empowerment, and accountability.
• Benefits include paid time off, health, dental and vision coverage, retirement benefits, and flexible spending accounts.
• Employees may participate in variable cash programs, including bonus or commission plans.