Manager, Quality Systems and Compliance (Biotechnology)

Location: Hybrid in Thousand Oaks, California, or on-site in Thousand Oaks or San Francisco

Company

hirify.global is a clinical-stage biotechnology company developing a biopharmaceutical pipeline.

What you will do

• Own the day-to-day operation, governance, administration, and continuous improvement of the electronic Quality Management System.
• Manage controlled documents, including SOPs, policies, work instructions, forms, templates, versioning, reviews, and archival.
• Maintain training management, curricula, training records, and completion tracking through the electronic Learning Management System.
• Manage deviations, investigations, CAPA, change control, quality metrics, and compliance trend reporting.
• Coordinate internal and vendor audits, track findings and commitments, and support regulatory inspection readiness.
• Collaborate with Quality Assurance, Clinical, CMC, Regulatory Affairs, vendors, consultants, and other GxP functions.

Requirements

• Bachelor’s degree in life sciences or a related field.
• At least 5 years of Quality Assurance or Quality Systems experience in the biopharmaceutical, biotechnology, or pharmaceutical industry.
• Working knowledge of GxP regulations and guidance from FDA, EMA, and ICH, as well as 21 CFR Part 11 and data integrity principles.
• Hands-on experience with an electronic QMS and core quality processes, including document control, training, deviations, CAPA, and change control.
• Experience supporting audits and/or regulatory inspections, with strong organization, attention to detail, and communication skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.

Nice to have

• Experience across GCP and/or GMP environments.

Culture & Benefits

• Hands-on role in a lean, fast-paced clinical-stage environment.
• Opportunity to mature and scale the Quality Management System as the organization grows.
• Focus on practical, phase-appropriate compliance and continuous improvement.