Manager, Quality Systems and Risk Management

About the role

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Responsibilities

• Lead formal risk management activities, including risk assessments and maintenance of risk registers
• Support maintenance and improvement of the Quality Management System (QMS)
• Manage preparation of Annual Product Quality Review (APQR) reports and ensure timely completion
• Generate Quality metrics and KPIs for Quality Management Reviews (QMRs)
• Execute process improvement initiatives using Lean Six Sigma principles
• Participate in audits and regulatory inspections
• Ensure compliance with GxP regulatory standards and internal procedures

Qualifications

• Bachelor's degree or equivalent in pharmacy, science, mathematics or engineering required
• At least 8 years of experience in a Biotech or Pharmaceutical FDA regulated industry in QA or related field
• Strong experience with formal risk management in a GxP environment using ICH Q9 and FMEA
• Preferred knowledge of Lean Six Sigma Methodologies
• Excellent analytical, problem-solving, and project management skills with attention to detail
• Familiarity with regulatory requirements (FDA, ICH, EU GMP, GDP)
• Proficiency in eQMS, preferably Veeva, Microsoft Office, and Google Docs

Benefits

• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• 100% employer-paid medical, dental, and vision premiums for employees and dependents
• Health Savings Account with employer contributions and Flexible Spending Accounts
• Flexible take-what-you-need paid time off and company-paid holidays
• Comprehensive paid medical and parental leave
• Opportunities for skill development and career paths through feedback and education programs