Quality Assurance Manager

Manager, QA OperationsJupiter, FLWho We AreMaravai 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 the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market.Your Next Role as a Miracle MakerMaravai LifeSciences is seeking a Miracle Maker to join our Quality Assurance team as a Manager, QA Operations. The Manager, QA Operations is responsible for the 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 ImpactManage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reportsImplement 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 findingsAuthor and maintain quality documentation, oversee timely reviews of all work instructions associated with production and quality control activitiesSupport Quality Control with customer complaints and Out of Specification (OOS) investigationsActively participate on core teams and provide deliverables from QA on quality processes and required documentation practices from production through testing and shipmentImplement and track metrics to monitor performance associated with Quality managementIdentify and implement efficiency improvement initiatives in support of Continuous ImprovementFacilitate proactive solutions by collecting and analyzing quality dataManage Internal Audit ProgramPerform other functions and duties as requiredThe Skills and Experience That You Will BringBachelor's Degree in Life Science, Biology, Chemistry or Pharmaceutical or related discipline3-5 years of managerial experience in non-academic biotechnology related industry1-3 years of supervisory experienceProven experience with: ISO 13485 certification, federal regulations 21 CFR 820 and 21 CFR Part 11Industry experience in a Good Manufacturing Practice (GMP) environment is preferredThorough knowledge of analytical testing industry standards and quality assurance methodologiesExcellent communication and presentation skills are requiredDemonstrated scientific "problem solving" skills, translated into consultative selling process where the "win" is for both the client and the companyAbility 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 companyProven ability to thrive in a start-up/change oriented environmentGreat attention to detail and results driven approachSelf-starter with ability to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achievedProven coaching, mentoring, team building and leadership skillsThe Benefits of Being a Miracle MakerYou 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 benefit and insurance options, including pet insurance.Retirement contributions.Holidays & Paid Time Off.Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & Growth site at a Maravai LifeSciences company, 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, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.HIRING SCAM ALERTRecently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.)Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at View email address on click.appcast.io. If you believe you have been a victim of fraud, you can report this activity at: or