Quality Assurance Manager

<p>The role of the QA Manager supports the EU Qualified Person in the activities performed at the testing and release laboratory in Seqirus Netherlands B.V. and provide services to</p><p>Seqirus Netherlands B.V. in relation to the MIA for the importation of material into the EU.</p><p>Performs release of intermediate products for Seqirus Netherlands B.V., completes final product release checks and recommends disposition of the</p><p>finished product to the EU Qualified Person.</p><p>Provides QA oversight of the QC operations in Amsterdam including equipment and method validation.</p><p>Delegates for the EU Qualified Person in meetings and for defined activities</p><p></p><p><b><span>Quality Assurance – Commercial / clinical batch release</span></b></p><ul><li><p><span>Provides QA services to Seqirus Netherlands B.V. in relation to the MIA for the importation of material into the EU.</span></p></li><li><p><span>Performs release of intermediate products for Seqirus Netherlands B.V., completes final product release checks and recommends disposition of the finished product to the EU Qualified Person.</span></p></li><li><p><span>Generates Lot Release Protocols and Marketing Information Forms and tracks national competent laboratory submissions for batch release.</span></p></li><li><p><span>Delegates for the EU Qualified Person in meetings and for pre-defined activities</span></p></li><li><p><span>Supports new product introduction and implementation of the global projects and changes at Amsterdam site.</span></p></li><li><p><span>Prepares, submits and tracks national competent laboratory submissions for batch release.</span></p></li><li><p><span>Supports data collation for the Qualified Person relating to IMP release</span></p></li></ul><p></p><p><b><span>Quality Assurance – QC support</span></b></p><ul><li><p><span>Performs monthly checks on the QC facilities and data integrity.</span></p></li><li><p><span>Reviews and approves validation protocols and reports and oversees validation activities.</span></p></li><li><p><span>Attends weekly compliance meeting and regular tiered accountability meetings with QC.</span></p></li><li><p><span>Supports annual retain inspection and inspection of retains for complaints/deviations.</span></p></li><li><p><span>Reviews and approves procedures, deviations (Level 1 and 2), OOS / OOT, root cause investigations, change controls and CAPAs for the QC laboratory.</span></p></li></ul><p></p><p><b><span>QMS related activities</span></b></p><ul><li><p><span>Actively involved in the site quality systems, risk assessments, and self-inspections.</span></p></li><li><p><span>Updates and Approves quality documentation relating to Seqirus Netherlands B.V.</span></p></li><li><p><span>Owns, Reviews and approves procedures, deviations (Level 1 and 2), Product Technical Complaints (minor and major) root cause investigations, change controls and CAPAs related to Seqirus Netherlands B.V.</span></p></li><li><p><span>Promotes a cGMP compliant culture, ensuring the highest standards are applied on the site, observing current regulations and procedures.</span></p></li><li><p><span>Participates/supports in inspections, audits and self-inspections, recalls and mock-recalls.</span></p></li><li><p><span>Supports implementation of commitments.</span></p></li><li><p><span>Coordinates PQR activities and generates and approves PQR reports.</span></p></li><li><p><span>Generates LQMR packs and presents data as required and generates monthly compliance KPI data</span></p></li><li><p><span>Attends CoP meetings on behalf of Seqirus Netherlands B.V.</span></p></li></ul><p></p><p><b><span>Education Requirements</span> </b></p><p>Minimum: Bachelors degree (BSc) in sciences</p><p>Preferred: Eligible to meet the education requirements to be an EU QP</p><p></p><p><b><span>Experience Requirements</span> </b></p><p><span>Minimum of 2 years of GMP industry experience; vaccines, steriles and biological experience is preferable</span></p><p>Experience of managing Quality Assurance procedures preferred</p><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><h2><b>About CSL Seqirus</b></h2><p>CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.</p><p>To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit <a target="_blank" href="https://www.csl.com/"><span style="color:#0875e1"><u>https://www.csl.com/</u></span></a> and CSL Plasma at <a target="_blank" href="https://www.cslplasma.com/"><span style="color:#0875e1"><u>https://www.cslplasma.com/</u></span></a>.</p><p> </p><p><b>Our Benefits</b></p><p>For more information on CSL benefits visit <a target="_blank" href="https://www.csl.com/careers/your-well-being"><span style="color:#0875e1"><u>How CSL Supports Your Well-being | CSL</u></span></a>.</p><p> </p><p><b>You Belong at CSL</b></p><p>At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.</p><p> To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging</p><p><b> </b></p><p><b>Equal Opportunity Employer</b></p><p>CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit <a target="_blank" href="https://www.csl.com/accessibility-statement"><span style="color:#0875e1"><u>https://www.csl.com/accessibility-statement</u></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Watch our ‘On the Front Line’ video to learn more about CSL Seqirus</span></b></p>