Associate Director, Head of Quality

Lonza·
Suzhou, CN
3mo ago
Full-timeEntryMasters

Description

<p style="text-align:inherit">&nbsp;</p><p style="text-align:inherit"></p><p><b>Quality Assurance</b></p><p>•       Oversee QA operations, including batch release, complaint handling, and cGMP compliance.</p><p>•       Represent the site during customer audits and regulatory inspections.</p><p>•       Collaborate with cross-functional teams to ensure quality standards in manufacturing.</p><p><b>Quality Control</b></p><p><b>•</b>      Lead QC functions covering Raw Material, Analytical, Microbiology, Biochemistry, and Environmental Monitoring.</p><p>•       Ensure timely testing and release of results, including Certificates of Analysis.</p><p>•       Develop and implement QC strategies aligned with business goals.</p><p><b>Quality Compliance</b></p><p><b>•</b>       Implement and maintain procedures in alignment with global and national cGMP regulations.</p><p>•       Translate global quality standards into site-level policies and practices.</p><p>•       Maintain site readiness for audits and certifications.</p><p><b>Customer Interface </b></p><p>•       Ensure all quality related customer complaints are investigated and handled in time.</p><p>•       Develop insights that can be used to enhance customer satisfaction or other metrics.</p><p>•       Identify when company and customer interest may not align and seeks effective solution to resolve or escalate.</p><p><b>Regulatory Affairs </b></p><p>•       Keep the site updated with the recent applicable regulations.</p><p>•       Coordinate with all functions to ensure site compliance with the latest requirement and monitor execution of the related action plan.</p><p><b>Strategy &amp; Continuous Improvement</b></p><p>•       Develop long-term and annual quality plans.</p><p>•       Lead quality improvement projects in line with the Operational Excellence strategy.</p><p>•       Drive strategic initiatives to strengthen quality systems and processes.</p><p><b>Resource Planning</b></p><p>•       Manage department budgets, staffing, and scheduling.</p><p>•       Ensure adequate resources are available to meet business and regulatory demands.</p><p>•       Prioritize quality initiatives to meet critical timelines.</p><p><b>People &amp; Leadership</b></p><p>•       Build and lead a high-performing quality team across QA, QC, and Compliance.</p><p>•       Implement team development, training, and succession plans.</p><p>•       Foster a compliant, efficient, and collaborative team culture.</p><p></p><p><b>Qualifications </b>  </p><p>•       Degree :Master degree,</p><p>•       Field of Study: Pharmacy, Chemistry, Biotechnology, Engineering</p><p>•       English: Business Fluent</p><p>•       Highly Experienced (10&#43; years) in Leading Senior Quality Function.</p><p>•       People management skills</p><p>•       Strong communication skills (vocal/written/presentation)</p><p>•       Strong execution skills (ability to plan and take activities to closure)</p><p>•       Project management skills</p><p>•       Strong analytical skills</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>
L

Lonza

CDMO

LocationBasel, Switzerland
Employees10001-50000
Open Jobs554
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Pipeline

Cross Training CourseN/A
Oceanix®N/A
arabinogalactanN/A
arabinogalactanN/A
L-CarnitineN/A