This position in R&D QA provides frontline QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Holly Springs, NC and related changes and deviations. Provides support in Holly Springs for assuring quality during GMP clinical manufacturing activities, liaising with site colleagues to align on the preferred approach for proposal to stakeholders. Supports the development and maintenance of quality procedures and systems related to area of expertise.
Provide Quality oversight of R&D activities
Ensures bulk and semifinished material for clinical batches comply 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.
Supports the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.
Reviews and approves executed batch records and development/validation/qualification protocols
Ensures data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP)
Authors phase appropriate FLQA procedures for oversight of clinical manufacturing activities
Provides QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required
Provides QA oversight to level 0 changes and minor deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations
Supports the implementation of the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organisations, and identified areas for continuous improvement
Establishes relationships with R&D QA and other global Quality functions:
Advises R&D on applicable requirements, partnering with more senior members in R&D QA 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)
Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)
Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving
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 with 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
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