Associate Director, Value Stream QA Bulk Lead
Responsibilities:
• Responsible for developing and implementing Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
• Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance
• Defines procedures governing quality systems processes: document management, change control, deviation handling, product quality review, training, supplier qualification and audit management
• Manages GMP and GQP systems for timely release of CSL products to the market
• Ensures preparation, successful conduct and follow-up of all regulatory inspections, self inspections and customer audits
• Collaborates cross-functionally to facilitate quality assurance training and communicate best practices
Qualifications:
• degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years' leadership/team management experience
• Experience with regulatory authorities and international inspections
• Demonstrated success in project management and business/QA systems
• Experience within a global matrix organization
• Knowledge of appropriate regulatory requirements including GMP/GQP
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!
Responsibilities:
• Responsible for developing and implementing Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
• Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance
• Defines procedures governing quality systems processes: document management, change control, deviation handling, product quality review, training, supplier qualification and audit management
• Manages GMP and GQP systems for timely release of CSL products to the market
• Ensures preparation, successful conduct and follow-up of all regulatory inspections, self inspections and customer audits
• Collaborates cross-functionally to facilitate quality assurance training and communicate best practices
Qualifications:
• degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 8-10 years' experience in quality/GMP in the pharmaceutical/biotech industry including 3+ years' leadership/team management experience
• Experience with regulatory authorities and international inspections
• Demonstrated success in project management and business/QA systems
• Experience within a global matrix organization
• Knowledge of appropriate regulatory requirements including GMP/GQP
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!
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