QMS Specialist, Quality Assurance (Biotech)

Location: San Diego, California, US; full-time, in-person presence required

Salary: $81,000–$103,000 annual

Company

hirify.global is a global biopharmaceutical company developing treatments for patients with serious and rare diseases, including gene therapy programs.

What you will do

• Oversee completion and QA review of QMS records, including change controls, CAPAs, deviations, document change controls, effectiveness checks, and periodic reviews.
• Administer the site Learning Management System, including user accounts, training curricula, ServiceNow tickets, and due-date tracking.
• Support Change Control Committee materials, review proposed changes, and facilitate feedback from committee members.
• Compile and present quality metrics, trend reports, and process improvement follow-up in Quality forums.
• Upload and route quality records in Veeva Quality Documents and perform document control reviews.
• Maintain SOPs and quality standards, support employee training, and assist with audit and inspection readiness.

Requirements

• BS degree in Chemistry, Engineering, Life Science, or a related discipline and/or 6 years of relevant Quality Assurance experience.
• Direct experience with change control, document control, deviations, CAPAs, and effectiveness checks in pharmaceutical or medical device products.
• Understanding of pharmaceutical cGMP requirements and familiarity with manufacturing, medical device, and analytical laboratory practices.
• Experience with electronic document management systems and reviewing procedural documents, manufacturing investigations, and laboratory investigations.
• Ability to manage projects and variable workloads with strong organization, attention to detail, accuracy, and concise communication.
• Proficiency in Microsoft Office and data trend analysis using Excel or Minitab.

Culture & Benefits

• Medical, dental, vision, mental health, wellbeing reimbursement, and Employee Assistance Program benefits.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible schedules with purposeful in-person collaboration.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, workshops, mentorship, leadership development, and employee resource groups.
• Volunteer, service, recognition, and networking opportunities.