Associate Director, Life Cycle Management Quality

7 days ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
**CSL Behring Australia** is undergoing positive change as we expand and grow. As we continue to evolve, a new position is available for an Associate Director, Life Cycle Management - Quality by Design Lead. This is an important global role and you will hold our Global Quality by Design (QbD) commercial product knowledge management strategy. You will be responsible for established processes from the development of the Process Control Strategy through to product retirement.

Establish and develop a team across our global CSL Behring manufacturing sites, you will work with the TGA, FDA and other national regulators, partners and product owners. You will also develop the Lifecycle management QBD framework to improve outcomes for the business.

Please note this is a 12 month fixed term / secondment position.

**The Role**:

- Prioritisation, strategy, and execution for generation/modernisation and maintenance of modern QbD packages for our existing products
- Develop and implement Lifecycle Management (LCM) QbD strategy and policies, Integration of process knowledge and understanding into modern QbD driven LCM Chemistry Manufacturing Controls (CMC) packages
- Consolidate QbD packages for products in routine manufacturing, development of strategies for incorporation process monitoring/trending data into modern LCM QbD packages and other main functions within the product lifecycle
- Promote reduced provisions and decreased major deviation rate, opportunity to accelerate and simplify deviation closure, support of Continuous Improvement programs
- Maintain QbD line-of-sight on product portfolio regulatory strategies in collaboration with Global Regulatory Affairs and important partners

**Your skills and experience**:

- Experience in QbD and / or CMC in Pharmaceutical, Chemical Manufacturing or similar industry
- Leading a high performing team. Influence project professionals and partners, including non‐specialists, at all levels in the organisation
- Demonstrated experience in managing, organising, developing and deploying best practice frameworks, processes, tools and templates in an Operations context, according to Enterprise standards
- Degree in engineering or science. Ideally having work experience in both R&D and process engineering

**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.

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