Manager, QA Operations

<p><a href="https://www.maravai.com/who-we-are/" rel="noopener noreferrer"><strong>Who we are</strong></a><strong>:</strong>&nbsp;</p>

<p>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.&nbsp;&nbsp;</p>

<p>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.&nbsp;</p><p><strong>Your next role as a Miracle Maker</strong>&nbsp;</p>

<p>Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a Manager, QA Operations. The Manager, QA Operations&nbsp;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.&nbsp; The Quality Assurance Manager is expected to ensure compliance with operational, statutory, and regulatory requirements in support of the Company’s business objectives.&nbsp;</p>

<p><strong>How you will make an impact:</strong>&nbsp;</p>

<ul>

<li>Manage Quality Assurance department day to day operations, including implementing training and performance management activities for direct reports&nbsp;</li>

<li>Implement and periodically evaluate documentation and policies to ensure continuous compliance&nbsp;to&nbsp;the quality, integrity, and efficiency standards set by the organization, the ISO 13485:2016 standard, and other statutory and regulatory requirements.&nbsp;&nbsp;</li>

<li>Collaborate with management to&nbsp;identify&nbsp;and fill documentation and process gaps&nbsp;required&nbsp;to maintain QMS compliance and address CAPAs, NCs, and audit findings&nbsp;</li>

<li>Author and&nbsp;maintain&nbsp;quality documentation, oversee&nbsp;timely&nbsp;reviews of all work instructions associated with production and quality control activities&nbsp;</li>

<li>Support Quality Control with customer complaints and Out of Specification (OOS) investigations&nbsp;</li>

<li>Actively&nbsp;participate&nbsp;on core teams and provide deliverables from QA on quality processes and&nbsp;required&nbsp;documentation practices from production through testing and shipment&nbsp;&nbsp;</li>

<li>Implement and track metrics to&nbsp;monitor&nbsp;performance associated with Quality management&nbsp;</li>

<li>Identify&nbsp;and implement efficiency improvement initiatives in support of Continuous Improvement&nbsp;</li>

<li>Facilitate proactive solutions by collecting and analyzing quality data&nbsp;</li>

<li>Manage Internal Audit Program&nbsp;</li>

<li>Perform other functions and duties as&nbsp;required&nbsp;&nbsp;</li>

</ul>

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