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
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Qualifications
Education:
• Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferred
Experience:
• 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
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!