Manager - Requalification

**Your role**

The Manager - Engineering Requalification is responsible for managing all aspects of the review and requalification activities across the CSL Broadmeadows site to ensure quality and regulatory requirements are met.

Reporting to the Senior Director (Manufacturing and Utilities) you will lead a team responsible for the implementation of Global Policies and procedures in relation to the Requalification of processes and equipment.

**Your responsibilities**
- Manage the Requalification activities including the preparation, review, implementation and maintenance of departmental documentation for Requalification activities (Standard Operating Procedures, Reports, etc)
- Work collaboratively with all stakeholders, Process Engineering Qualification & Validation Production, R&D, QC staff and others, to ensure the requalification activities are planned and delivered in an efficient timeframe
- Promote the education and implementation of the lobal Engineering Standards & relevant regulatory requirements including the TGA Code of Good Manufacturing Practice, Code of Federal Regulations and other industry regulations and guidelines.
- Actively support regulatory inspections through ensuring all documentation is current and your team are capable of delivering content the group is responsible for.
- Assist in budget preparation and forecasting. Manage budgets allocated to the group, providing timely and accurate reports as required.

**Your experience**
- A relevant Science or Engineering tertiary qualification and demonstrated experience leading a technical team in a regulated environment
- At least 10years experience in the pharmaceutical (or other regulated manufacturing) industry with demonstrable experience in qualification / requalification
- Direct involvement with the regulatory aspects of the pharmaceutical industry through exposure to regulatory audits with particular emphasis to TGA and FDA regulatory environments would be an advantage

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**: