- You will report into the Sr. Director Affiliate Quality Operations
- Managing the global affiliate quality management system compliance activities to ensure all policies, SOPs and work instructions remain up to date, are fit-for-purpose, harmonized and facilitate across the end-to-end global and local process workflow. Lead the update of procedures.
- Work with the Affiliate Quality Leadership Team to identify Policy Owners, Business Process Owners and Local Process Champions and ensure Affiliate Quality Operations is represented at all Policy Governance Councils and communities of practice. Summarize main tasks and contribute to operational task planning.
- Represent Affiliate Quality in Quality Management System Change Management meetings and escalate to Affiliate Quality Leadership Team proposed changes. Be the Change Coordinator for global or regional changes impacting the quality QMS within the affiliates and regions.
- Help develop training criteria for Global Affiliate Quality teams across the affiliate network
- Support Global Quality in inspection readiness by providing relevant data, updating existing presentations and statements, reviewing presentations, and being the Subject Matter Expert (SME) during internal audits and external audits by regulatory agencies or customers.
- Consolidate and aligns with the AQOLT any Regions needs for technology (platforms, tools) and supports the creation of a formal business case, liaises with related Global Quality or ex-Global Quality functions as is appropriate.
- Support deputy activities of regional affiliate quality lead and local quality officers when needed to include releasing product as deputy Local or Regional Quality Officer
- 5+ years' experience in a pharmaceutical or biopharmaceutical company
- 5+ years' direct experience with QMS development and improvement at a local and/or global level.
- 2+ years' experience executing Quality Assurance/Quality systems activities required
- Experience in interacting with regulatory authorities including regulatory inspections a plus
- Experience in project management highly preferred
- In-depth knowledge of US, European, and/or Australian applicable regulations.
Fluency in English (written and spoken) required. Foreign language skills (especially Spanish and/or German) are beneficial. This role does not require travel.
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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, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!