Manager, QA Operations

Who we are :  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 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 equitableculture 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 Maker   Maravai LifeSciences is seeking a #MiracleMaker 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 impact:   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       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 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   #LI-Onsite The benefits of being a #MiracleMaker:  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.  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   https://www.maravai.com/careers/benefits-and-growth/   To view more opportunities to become a #MiracleMaker, visit our career site at    https://www.maravai.com/careers/    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, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.  Click here to view Maravai LifeSciences Privacy Notice   HIRING SCAM ALERT  Recently, 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 in