Vice President, Csl Behring Quality

Reporting to the SVP CSL Behring Operations, the VP CSL Behring Quality will be responsible for the Quality strategy and leading the Quality function of the Behring Business Unit. The Quality function will ensure products, services and operations are in compliance from product idea generation to product retirement, regulatory and company specific requirements and guidelines. The function also ensures drug safety/ donor safety and coordinates respective measures/procedures in alignment with overall objectives, regulations and medical practice

The function drives alignment across CSL Behring Business Unitin regards to Quality and Compliance standards through establishment of governance oversight, process and system standardization and strategy implementation. Through partnerships, S/He will work with Behring Operations, plasma collection sites, clinical operations and early R&D to assure preparedness for product approvals, inspections, identification of compliance vulnerabilities and responses to any inspectional observations.

Establishes and implements strategies that have mid
- to long-term impact on business results

Responsible for all final decisions on product quality including product withdrawals, recall and field actions.

Works with Quality functions to monitor, manage and enhance compliance, assuring awareness of, and compliance with external requirements, conformance to internal requirements and assessing non-compliance risk level with the intent of meeting the industry standard of compliance on a worldwide basis. Develops and supports initiatives to enhance/improve GMP compliance and drive continuous improvement. Establishes and oversees implementation of broad policies on Quality and Compliance for the company.
- Interacts with FDA and other relevant regulatory bodies when required on all quality and compliance related matters. Constantly monitors adverse events, technical complaints, and quality metrics.
- Monitors, interprets, influences and internally communicates to senior management on a regular and continuing basis regarding the company’s quality and compliance status. Establishes criteria for measuring compliance to assure preparedness for inspections, or audits by regulatory authorities or third parties. Identifies vulnerabilities and provides appropriate corrective actions.
- Represents CSL within PPTA and other trade associations for quality and regulatory matters related to the development, manufacture, packaging and distribution of plasma derived protein therapeutics.
- Actively sponsors and champions improvements in productivity and efficiency in all areas of the company and responsible for cost of Quality.
- Develops professional capabilities of team and ensures education of Quality group employees regarding national and international GMP standards.
- Encourages a culture of continuous improvement to drive development and operational excellence.

Bachelor’s Degree related to science or medicine; relevant post graduate qualifications (Masters, PhD) preferred.
- 12-15 years' experience in pharmaceutical, biotechnology or
- Related industry including direct and indirect supervision of technical specialists.
- Significant exposure to Good Manufacturing Practices (cGMPs)
- Significant experience in Quality Assurance, Production or Regulatory Affairs with increasing responsibilities Demonstrated ability to establish professional relationships with government regulators.
- Preference for experience in biologics and/or biotechnology.
- Experience in blood products manufacturing and technology is preferred.
- International experience highly desirable.
- Foreign language skills (especially German) beneficial.

**Our Benefits**:
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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 and inclusion. Learn more about Diversity & Inclusion at CSL.

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