Manager, QA Operations

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within nucleic acid production and biologics safety testing. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture, we cultivate an environment where we lead together, providing differentiated value to our customers. Your next role as a Miracle Maker Maravai LifeSciences is seeking a Miracle Maker to join our Quality Assurance team as a Manager, QA Operations. The Manager, QA Operations is responsible for implementation of policies and procedures to ensure adherence to production quality standards and oversight of the Company’s electronic ISO 13485:2016 Quality Management System. The Quality Assurance Manager is expected to ensure compliance with operational, statutory, and regulatory requirements in support of the Company’s business objectives. How you will make an impact Manage daily operations of the Quality Assurance department, including implementing training and performance management activities for direct reports Implement and periodically evaluate documentation and policies to ensure continuous compliance with 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 The skills and experience that you will bring Bachelor’s Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline 3-5 years of managerial experience in 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 Demonstrated scientific problem solving skills, translated into consultative selling process where the win is for both client and company Ability to participate with others as a member of the team to ensure demanding and difficult projects are handled smoothly and cooperatively 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 growth and success of company is achieved Proven coaching, mentoring, team building and leadership skills The benefits of being a Miracle Maker 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. Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including sexual orientation), gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr Maravai LifeSciences