Senior Manager, Quality (Biotech)

Location: Marlborough, Massachusetts, United States

Estimated base salary: $135,000–$190,000 per year, plus eligibility for variable cash programs and equity for eligible roles.

Company

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

What you will do

• Maintain compliance across the Quality Management System, including audits, CAPA, nonconforming materials, validation, and document control.
• Lead, mentor, and develop direct reports while building accountability, collaboration, and continuous learning.
• Partner with site leadership and global quality stakeholders on enterprise-wide quality processes.
• Develop and communicate quality metrics and KPIs to identify trends and support data-based decisions.
• Oversee investigations, deviations, out-of-specification results, risk assessments, and corrective actions.
• Lead continuous improvement and digital transformation initiatives, including the transition to electronic quality systems.

Requirements

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline.
• At least 10 years of experience in an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
• At least 4 years of people leadership experience, including coaching, mentoring, and developing direct reports.
• Expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
• Knowledge of Good Documentation Practices, root cause analysis, quality investigations, metrics, and project management.
• Ability to lead cross-functional initiatives, influence stakeholders, and balance strategic priorities with day-to-day execution.

Nice to have

• Experience leading quality system improvements, transformation initiatives, or digitalization projects.
• Lean, continuous improvement, or operational excellence experience.

Culture & Benefits

• Leadership behaviors 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.
• Additional compensation may include variable cash programs and equity for eligible roles.