Senior QA Manager- Batch Review

Jobinhalt

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.

We are currently looking for an experienced Senior QA Manager- Batch Review to be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

You will be responsible for Leading, managing and developing the QA Operations team and direct reports to assure effective operational performance and compliance.

Whilst actively developing, mentoring, training and instilling a site GMP culture.

Supporting QA Leadership with department strategy development, objectives & goal setting, project prioritization activities.

Key Responsibilities

• Manage and escalate major/critical compliance issues through the site.
• Responsibility of the Auditing teams, co-ordinating of review and any follow-up actions/corrections of GMP documentation.
• Acting as a point of contact for queries relating to Quality and escalating as required.
• Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.
• Oversight of Vials and releasing of Cell Banking documentation for QP release.
• QP batch pre-disposition support.
• Assist in preparation of area for inspection readiness.
• Identify discrepancies and deviations and to distinguish appropriate classification and appropriate follow-up actions in areas where trained.
• Developing ability to interpret and apply GMP regulations consistently.
• Mentor and train other departments in QA skills and knowledge.
• DMS document editor for document errors identified in QA.
• Performs basic document reviews of SOP’s, batch records, test methods, and logbooks
• Deviation QA approver for Minor deviations/CAPAs/tasks and HOLD notices.
  

What We Need You To Have

• BSc in Life Sciences
• Extensive experience within Quality Assurance in a GMP environment.
• Previous experience within a Leadership role, have the ability to manage team of 5 direct and 40 indirect.
• Strong organisational skills, ability to manage multiple projects.
• Strong IT skills including MS Office – Word, Explorer, Excel, Access, Outlook.
  

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 achieved 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.