Manager, R&D QA Batch Release
With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!
This position in Chemistry, Manufacturing and Controls (CMC) and Reseach QA (CRQA) is responsible for release of intermediate, semi-finished and investigational and comparator products for clinical trialsand provides strategic support globally as an expert in assuring quality during R&D, arranging audits of third party suppliers/venders/CROs/CMOs for supplier qualification, deviations and changes involving R&D activities, and product technical complaints. Provides strategic and technical expertise to R&D in all GMP and procedural compliance-related matters.Major Responsibilities:
Provides quality oversight of R&D activities
Ensures material for clinical batches being released complies with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.
- Ensures that batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, etc. comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
- Reviews and approves executed batch records, certificates of analysis, analytical data, development/validation/qualification protocols and reports, product specification file (PSF) for compliance and completeness.
- Coordinates batch release activities with R&D and commercial QA/Qualified Person (QP) as required, including the sponsor release for the clinical trial; establishes phase appropriate batch release procedures and as required serves as Release-Responsible Person
- Provides QA oversight as needed to the manufacture, distribution and testing of products under development in R&D, either in-house or at third party suppliers, including sterile manufacturing and liasing with global sterility assurance as required
- May provide direct line management for the day to day activities of a small team of 1-2 QA specialists, managing their performance and development
Establishes relationships with R&D QA and other global Quality functions:
- Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance, as well as upcoming industry trends, to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D and applicable sites for relevant markets
- Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPAs, internal audit processes, commitments to Health Authorities
- Ensures proper knowledge transfer to Site Quality during Technical Transfer to manufacturing sites
- Reviews and approves SOPs, Work Instructions and other procedures for R&D activities within area of oversight, ensuring compliance with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
In collaboration with R&D QA and other global Quality functions:
- Ensures risks to compliance are escalated to senior management and supports identification of mitigations and backup options with cross-functional colleagues
- Supports internal audits, helps prepare for regulatory inspections and serves as subject matter expert for applicable area of oversight
- Supports inspection finding responses related to production, distribution, testing and release of material for clinical trials
- Supports the provision of accurate and timely reports on metrics, findings, risks and trends stemming from audits, inspections and deviations for management review and proposes and/or implements improvement initiatives.
- Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
- 5+ years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
- Sterile product manufacturing knowledge and experience in aseptic processing in Biologics required.
- Experience working directly within or directly supporting a clinical or commercial manufacturing environment is required.
- Raw Material, Drug Substance and Drug Product expertise in vaccines preferred (cell-based and/or Advanced Therapeutic Medicinal Products)
- Experience working across different phases of R&D preferred (Product Development/GLP Toxicology, Clinical Phse 1, 2 and 3 and commercialization)
- Experience applying GMP principles in different market areas (e.g., US and EU) preferred