Director, Quality Systems

📋 Description

• Develop, implement, maintain, and continuously improve an integrated QMS covering GxP activities
• Own and optimize key quality processes, including deviations, corrective and preventive actions
• Provide quality oversight and approval of computerized system validation deliverables and related
• Establish meaningful quality metrics, prepare quarterly dashboards, lead Quality System Management
• Oversee complaint intake, documentation, investigations, coordination with outsourced vendors, and
• Lead inspection preparation, support regulatory inspections and audits, including Pre-Approval

🎯 Requirements

• Bachelor's degree in a scientific discipline or related field; an advanced degree is an advantage.
• At least 8 years of experience in GxP Quality within the biotechnology or pharmaceutical industry
• Demonstrated experience leading quality professionals and building, implementing, or managing a
• Strong knowledge of enterprise QMS processes, including deviations, CAPA, change control, document
• Expertise in computerized system validation or computer software assurance, including lifecycle
• Direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs).

🎁 Benefits

• Base salary: $220,000–$235,000 USD annually, depending on experience, skills, qualifications, and
• Annual incentive: Eligible for an annual target bonus.
• Equity compensation: Eligible for equity compensation, subject to the compensation committee's
• Healthcare: Medical, dental, and vision insurance.
• Retirement and savings: 401(k) retirement plan and participation in an Employee Stock Purchase Plan.
• Insurance protection: Company-paid life insurance and short- and long-term disability coverage.