Senior Manager, Value Stream QA Support Lead
Responsibilities:
• Responsible for maintaining Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
• Manages GMP and GQP systems for timely release of CSL products to complex markets
• Leads/coordinates complex deviations, recalls and reporting of product technical complaints and ensures remedial actions are implemented as required
• Supports preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required
• Ensures correct response to questions from authorities, maintaining relationships with authorities to ensure efficient product release
• Establishes and maintains GXP training and site quality policies, SOPs and work instructions
Qualifications:
• degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience
• Experience within a global matrix organization
• Demonstrated success in project management and business/QA systems
• Knowledge of appropriate regulatory requirements including GMP/GQP
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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 maintaining Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
• Manages GMP and GQP systems for timely release of CSL products to complex markets
• Leads/coordinates complex deviations, recalls and reporting of product technical complaints and ensures remedial actions are implemented as required
• Supports preparation, successful conduct and follow-up of regulatory inspections, self inspections and customer audits as required
• Ensures correct response to questions from authorities, maintaining relationships with authorities to ensure efficient product release
• Establishes and maintains GXP training and site quality policies, SOPs and work instructions
Qualifications:
• degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
• 7+ years' experience in quality/GMP in the pharmaceutical/biotech industry including 1-3 years' leadership/team management experience
• Experience within a global matrix organization
• Demonstrated success in project management and business/QA systems
• Knowledge of appropriate regulatory requirements including GMP/GQP
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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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