Manager, Clinical Supply QualityUnited States of AmericaR-1023892012 CSL Behring L.L.C.
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Manager, Clinical Supply Quality is a leadership role within CSL Behring Global R&D Quality that is directly responsible for the operational quality support for the supply of CSL Behring’s early and late stage clinical trials worldwide.
• Performs clinical trial sponsor release, ensuring a complete Product Specification File (PSF) from batch certification through regulatory approval over the lifecycle of the clinical trial. Ensures that the quality management of investigational medicinal products (IMP) and auxiliary medicinal products (AMP) sponsored by CSLB for use in a clinical trial are in accordance with Good Clinical Practice (GCP) and applicable regulations, which are at the interface with and complementary to Good Manufacturing Practices (GMP).
• Responsible for managing Quality Systems in support of Clinical Trial Supply. Perform oversight of deviations, corrective / preventative actions (CAPAs), effectiveness checks, and quality metrics impacting CSL IMP and AMP. Performs transport verification on shipments of clinical material to depots.
• Performs Regulatory surveillance of requirements related to the supply of IMP and AMP for clinical trials.
• Provides QA operational support of CTS quality system activities including: deviation management, CAPA, change management, PTCs, audit/inspection follow-up, document and training management, vendor management and IT systems.
• Supports the Head of Clinical Supply Quality in implementation of relevant Quality initiatives intended to drive compliance within CTS and its vendors.
• Ensures that IMP is labelled and packed consistent with clinical trial designs, in accordance to CSLB release specifications and in compliance with respective regulations determined by international and local standards and requirements.
• Ensure that CSLB quality standards are globally in place for approved non-CSL Behring sponsored initiatives such as Investigator Initiated Trials (IITs), expanded access/compassionate use programs and “post-study pre-marketing authorization” studies.
• University degree (BSc/MSc) in scientific discipline/life sciences or related discipline
• 5+ years' experience in CQA compliance at a pharmaceutical company or clinical research organization
• Knowledge of Good Clinical and Good Laboratory and Quality Management System/audit procedures, reporting and CAPA management
• Thorough knowledge of drug development process and international and national regulations
• Demonstrated leadership and management skills
Minimum of 8 years experience in a pharma/biopharmaceutical industry
At least 5 years experience in a Quality Assurance role with demonstrated knowledge and experience in GCP/GMP/GDP principles as related to clinical drug supply and relevant international standards and regulatory requirements/regulations related to clinical trial sponsor release