Sr. Specialist, 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 CMC and Research QA (CRQA) supports the review of clinical trial material while ensuring compliance with cGMPs, SOPs, and regulatory requirements. Provides support globally in assuring quality during R&D, deviations and changes involving R&D activities, product technical complaints. Responsible for the development and maintenance of quality procedures and systems related to area of expertise.Major Responsibilities
Provide Quality oversight of R&D activities
Reviews 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; complies with phase appropriate batch release procedures
- Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing batch release activities
- Ability to identify non-compliances impacting release and report as appropriate for resolution
- 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
- Performs minor deviations investigations and product technical compliant investigatons
- Performs data verification checks as needed for data obtained from area of oversight being provided to regulatory authorities (e.g., approving data included in source documents, regulatory filings or communications with health authorities)
Establishes relationships with R&D QA and other global Quality functions:
- Advises R&D on applicable requirements, partnering with more senior members in CRQA for complex issues
- Acquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets
Helps maintain the Quality System in R&D
- Identifies and escalates risks to compliance to senior management
- Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
- Supports internal audits and helps prepare for regulatory inspections
- Supports inspection finding responses related to applicable area of oversight
- Supports the provision of accurate and timely reports on metrics, findings, risks and trends
- Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
- 3+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.
- Previous work in a QC, Research, Development, Manufacturing or Quality role required.
- Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)