Sr. Specialist, QA GxP Lab
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) is responsible for QA oversight of lab-based / small-scale activities performed at the site level by R&D under non-regulated and/or GLP conditions, as well as development according Quality by Design principles and preparations for tech transfer into the GMP area, to confirm compliance with GxP and Seqirus procedures and data integrity are maintained. Responsible for the development and maintenance of quality procedures and systems related to area of oversight.Major Accountabilities:
Provide Quality oversight of R&D activities primarily at the site level
- Confirms as applicable that activities in Technical Development (TD) and as needed in Research are compliant with GLP and/or procedural requirements in Seqirus and data integrity is maintained on an ongoing basis.
- Responsible for the development of Quality Systems in area of oversight. Responsible for authoring standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility for management approval. Supports implementation.
- Reviews documentation for compliance, completeness and data integrity.
- Issues laboratory notebooks and reviews and archives complete notebooks, assists with archiving of other documents
- Provides frontline QA oversight as needed to lab-based / small-scale work (e.g., technical study execution, sample testing, sample distribution, etc.), either in-house or at third party suppliers.
- 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 TD to support day-to-day activities
- Advises R&D on applicable requirements, deferring to 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 oversight 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 laboratory (in vitro and/or animal studies) 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)
- Requires in-depth conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)
- Provides technical advice on issues within own discipline
- Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product
- Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change
- Effective verbal & written communication skills in a cross functional environment and attention to detail
- Ability to present solutions to complex and strategic issues
- Evidence of commercial awareness in technical strategies
- Excellent customer focus with demonstrated management of customer expectations
- Effective presentation skills