Manager, QA Operations

About the role

The Manager, QA Operations role at Maravai LifeSciences is responsible for ensuring adherence to production quality standards and overseeing the Company’s electronic ISO 13485:2016 Quality Management System. This position requires a Bachelor’s Degree in Life Science, Biology, Chemistry, or Pharmaceutical or related discipline, along with 3-5 years of managerial experience in a non-academic biotechnology industry and 1-3 years of supervisory experience.

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 the quality, integrity, and efficiency standards set by the organization, the ISO 13485:2016 standard, and other statutory and regulatory requirements
• Collaborate with management to identify and fill documentation and process gaps required to maintain QMS compliance and address CAPAs, NCs, and audit findings
• Author and maintain quality documentation, oversee timely reviews of all work instructions associated with production and quality control activities
• Support Quality Control with customer complaints and Out of Specification (OOS) investigations
• Actively participate on core teams and provide deliverables from QA on quality processes and required documentation practices from production through testing and shipment
• Implement and track metrics to monitor performance associated with Quality management
• Identify and implement efficiency improvement initiatives in support of Continuous Improvement
• Facilitate proactive solutions by collecting and analyzing quality data
• Manage Internal Audit Program
• Perform other functions and duties as required

Requirements

• Bachelor’s Degree in Life Science, Biology, Chemistry, or Pharmaceutical or related discipline
• 3-5 years of managerial experience in non-academic biotechnology related industry
• 1-3 years of supervisory experience
• Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
• Industry experience in a Good Manufacturing Practice (GMP) environment is preferred
• Thorough knowledge of analytical testing industry standards and quality assurance methodologies
• Excellent communication and presentation skills are required
• Demonstrated scientific “problem solving” skills, translated into consultative selling process where the “win” is for both the client and the company
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
• Proven ability to thrive in a start-up/change oriented environment
• Great attention to detail and results driven approach
• Self-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
• Proven coaching, mentoring, team building and leadership skills

Qualifications

• Proven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11
• Industry experience in a Good Manufacturing Practice (GMP) environment is preferred

Skills

• Thorough knowledge of analytical testing industry standards and quality assurance methodologies
• Excellent communication and presentation skills
• Demonstrated scientific “problem solving” skills
• Ability to participate with others as a member of the team
• Proven ability to thrive in a start-up/change oriented environment
• Great attention to detail and results driven approach
• Proven coaching, mentoring, team building and leadership skills

Benefits

• You have the potential to change, improve, and save lives around the world.
• You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• We offer comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Roth and Traditional 401(k) retirement contributions.
• Holidays & Paid Time Off.

Pay

Details on compensation are confidential and will be shared during the interview process.

Schedule

Details on schedule are confidential and will be shared during the interview process.