Quality Systems Manager (Biotech)

Location: Must be based in or able to work on-site in Framingham, MA (4 days/week)

Salary: $134,000–$173,500 per year

Company

hirify.global is a biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies designed to transform cancer treatment.

What you will do

• Lead the administration, optimization, and continuous improvement of electronic Quality Management Systems (eQMS).
• Serve as a subject matter expert for Veeva Quality applications and support MasterControl governance.
• Provide cross-functional support for GxP activities and lead quality process remediation initiatives.
• Author, review, and approve quality documentation including SOPs and quality reports.
• Support regulatory inspection activities and internal/external audits as a Quality Systems SME.
• Analyze and report quality metrics and KPIs to ensure compliance and support management reviews.

Requirements

• Bachelor's degree in a relevant field with experience in a regulated manufacturing environment.
• Minimum of 7 years of experience in pharmaceutical, biotechnology, or related regulated industries.
• Extensive experience administering Veeva Quality applications and eQMS.
• Strong understanding of FDA, EU, ICH, and GxP regulatory requirements.
• Ability to work on-site in Framingham, MA, with a 4-day weekly expectation.
• Proficiency in Microsoft Office suite and experience with data integrity principles.

Nice to have

• Advanced degree.
• Experience administering MasterControl.
• Experience supporting commercial GMP manufacturing operations.
• Experience leading cross-functional Quality Systems initiatives.

Culture & Benefits

• Competitive total rewards program including annual performance incentive bonuses and equity.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401k match program.
• Flexible time off and paid holidays, including a year-end shutdown.
• Collaborative, mission-driven culture focused on transforming cancer care.