Section Manager, QA
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Section Manager, QA will be responsible to lead a team of QA Specialist and is responsible for supporting Lonza's internal and external customers with deviation, CAPA, and change control management; and preparation, review and approval or Product Quality Report (PQR) sections relating to quality. The Manager ensures staff is meeting objectives and deliverables on time and in-full, performs key functions such as lot review and supports the overflow of tasks as needed to ensure deliverables are met.
- Manage a team QA Specialist for GMP production batch records and logbooks review
- Manage and coordinate lot review schedule to ensure timely completion of lot review activities to support lot release schedule
- Review and approve temporary change request to support production activities
- Provide quality assessments for events occurred in manufacturing operation
Process-related Changes, Deviations and CAPAs
- Review, approve changes, deviations and CAPAs to ensure compliance with cGMP
- Assessment of potential impact to product quality for open deviations during lot release
- Approval of minor events, as required
QA oversight to Manufacturing process operations
- Review and approve Manufacturing SOPs
- Review and approve process descriptions and master batch records
- Review completed GMP records to ensure compliance with cGMP per written procedures (eg manufacturing critical logbooks, batch records, changeover records)
- Participate and support improvement projects related to Manufacturing process operation
- Participate in walkthroughs and internal audit program
Annual Product Reviews and Customer Quality Management Review
- Support timely completion of Annual Product Reviews
- Prepare, support and oversee conduct of and timely completion of QMR with customer
- Support training of new team members
- Work effectively with Program Management, site and customer as QA Project Lead for assigned projects
- Prepare responses for customer review observations
- Manage customer complaints
Quality Operations Systems
- Provide oversight to the Quality Tag Out system for Manufacturing
- Maintain the Final Labelling system
Implement ideas for system improvements
and supporting as needed in the following:
- Customer and/or Regulatory Audits or meetings
- Any other duties assigned by Supervisor/Manager.
- Degree or higher from recognized institution with significant years of experience in Operations / Quality / Validation unit in the pharmaceutical/biotech industry
- Relevant QA Operations background from the Biopharma environment
- Hands-on experience coordinating & interacting with internal departments on supporting manufacturing activities
- Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA,
- and ICHQ7)
- Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
- Good leadership and interpersonal skills
- Effective Communicator (oral and written)
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Team player, with strong focus on safety, quality and timelines.
Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieve ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.