**The Opportunity**:
Join the **CSL Behring** Quality Assurance (QA) Compliance team on a **full-time ongoing** basis. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.
Reporting to the Associate Director, Value Stream Quality Lead - Filling, and working **on site** at **Broadmeadows**, you will assure the appropriate quality of systems and processes, following CSL standards and procedures, review and approval of related records, support quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and contribute to the continuous improvement of quality performance metrics. You will also manage a team, provide quality guidance to the filling team and be the quality contact for escalations.
**The Role**:
As the **Manager QA Value Stream - Filling & Visual Inspection,** you will:
- Manage and oversee all aseptic filling and support related activities to provide real time (GEMBA) and post event (CCIT) review of process steps, media filling; and visual inspection oversight, documentation, activities and behaviour;
- Support product quality and compliance partnering with all teams within the site value streams regarding quality aspects;
- Manage and approve deviation processes, including initial risk assessment meetings, creation of environmental / personnel trends, root cause analysis, development and agreement of CAPAs and analysis of repeat issues;
- Perform QA review and approval of operational, processing and records to ensure regulatory compliance with Australian, EMEA and USA regulatory requirements;
- Participate to support batch document review and manage change controls to ensure that planned implementation actions are appropriate and supported by relevant level of risk statements;
- Lead and influence continuous improvement activities including global harmonisation projects and 'Right First Time' projects.
**Your skills and experience**:
To be considered for this role you have:
- A degree in science or engineering or pharmaceutical science;
- 5+ years' experience in a similar role in pharmaceutical manufacturing, quality compliance;
- 3+ years' experience with the aseptic filling;
- Experience with cGxP regulatory requirements including risk-based decisions, inspections and industry guidance documents such as those required by TGA or FDA;
- Experience leading a technical team in a regulated environment and providing technical support;
- Experience preparing written technical documents and presenting complex information;
- Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities;
- Flexibility to support out of hours media fills or other quality escalations.
**How to Apply**:
**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**: