Manager, QA & Regulatory Affairs

Location: San Diego, California, USA

Base compensation: $119,000–$148,875 per year. Additional potential compensation includes a 15% annual bonus opportunity and a $14,000 annual equity award.

Company

Develops the MassARRAY System, an advanced platform that enables research laboratories to generate targeted genomic data for mutation profiling, liquid biopsy, pharmacogenetics, and related applications.

What you will do

• Manage the implementation, maintenance, and effectiveness of assigned Quality Management System elements.
• Lead regulatory activities supporting product development, market access, product changes, submissions, registrations, and lifecycle management.
• Lead, coach, and develop Quality Assurance and Regulatory Affairs employees while assigning work and managing team resources.
• Maintain audit and inspection readiness and coordinate responses to audit observations, nonconformances, and regulatory findings.
• Manage root-cause investigations, CAPA activities, risk mitigation, and continuous improvement initiatives.
• Partner with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and regulatory issues and report metrics, risks, and program status.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline, or an equivalent combination of education and experience.
• Typically 6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a regulated environment.
• Typically 2–3 years of people leadership, supervisory, team lead, or equivalent demonstrated leadership experience.
• Working knowledge of Quality Management Systems, regulatory compliance frameworks, audits, CAPA, nonconformance management, change control, risk management, and product lifecycle activities.
• Strong analytical, problem-solving, communication, influencing, organizational, and project management skills.
• Ability to work onsite in San Diego, California, USA.

Culture & Benefits

• Benefits eligibility begins on the first day of the month after starting.
• Medical, dental, vision, HSA, and healthcare and dependent-care FSA options.
• Flexible time off, 48 hours of paid sick leave annually, nine paid company holidays, and caregiver leave eligibility.
• Company-paid short- and long-term disability, life insurance, and AD&D coverage.
• 401(k) plan with a 4% Safe Harbor company match on a 4% employee contribution beginning on day one.
• Employee wellness and financial assistance resources.