Manager, QA Operations

Responsibilities

• Manage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reports
• Implement and periodically evaluate documentation and policies to ensure continuous compliance to ISO 13485:2016 and other regulatory requirements
• Collaborate with management to identify and fill documentation and process gaps to maintain QMS compliance and address CAPAs, NCs, and audit findings
• Author and maintain quality documentation and oversee reviews of work instructions for production and quality control
• Support Quality Control with customer complaints and Out of Specification (OOS) investigations
• Participate in core teams to provide QA deliverables from production through testing and shipment
• Implement and track metrics to monitor Quality management performance
• Identify and implement efficiency improvement initiatives for Continuous Improvement
• Manage the Internal Audit Program

Requirements

• Bachelor’s Degree in Life Science, Biology, Chemistry, Pharmaceutical, or related discipline
• 3-5 years of managerial experience in a non-academic biotechnology related industry
• 1-3 years of supervisory experience
• Proven experience with ISO 13485 certification, 21 CFR 820, and 21 CFR Part 11
• Thorough knowledge of analytical testing industry standards and quality assurance methodologies
• Excellent communication and presentation skills
• Proven coaching, mentoring, and team building skills

Preferred Qualifications

• Industry experience in a Good Manufacturing Practice (GMP) environment

About the Company

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies deliver novel vaccines, therapeutics, and diagnostics.