Senior Manager, QA & Regulatory Affairs

Location: 4755 Eastgate Mall, San Diego, California 92121, USA

Base compensation: $154,500–$193,250 USD annually

Company

hirify.global develops products and platforms that support scientific research, product integrity, patient and worker safety, and quality of life. Agena Bioscience provides the MassARRAY System for scalable targeted genomic data and research applications.

What you will do

• Oversee the design, implementation, maintenance, and continuous improvement of the Quality Management System.
• Direct Regulatory Affairs strategies, regulatory submissions, change notifications, and communications with regulatory bodies.
• Lead internal and external audits, inspections, regulatory assessments, and responses to findings and nonconformances.
• Manage CAPA programs, root-cause investigations, risk mitigation, and effectiveness monitoring.
• Lead and develop managers and individual contributors across Quality Assurance and Regulatory Affairs.
• Partner with Engineering, Operations, Supply Chain, R&D, and Commercial teams to integrate quality and regulatory requirements into product and business processes.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline.
• 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs.
• 4–5 years of people management experience leading managers and/or cross-functional teams.
• Strong knowledge of Quality Management Systems and regulatory compliance frameworks.
• Experience leading audit programs, CAPA systems, compliance initiatives, and quality-risk mitigation.
• Strong analytical, problem-solving, decision-making, communication, and influencing skills.

Culture & Benefits

• Annual bonus opportunity of 17% based on company performance.
• Annual equity award of $17,500.
• Medical, dental, vision, HSA, and healthcare and dependent care FSA options.
• Flexible time off, paid sick leave, paid caregiver leave eligibility, and nine company holidays.
• Company-paid disability, life insurance, and AD&D coverage.
• 401(k) plan with a 4% Safe Harbor company match beginning on day one.