Job Purpose:

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 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. Develop and maintain quality procedures and systems related to area of oversight.

Major Responsibilities:

Provide Quality oversight of R&D activities

• Confirm as applicable that activities in Technical Development (TD) and in Research are compliant with GLP or procedural requirements in Seqirus and data integrity is maintained on an ongoing basis.
• Develop Quality Systems in area of oversight. Develop and implement standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility.
• Review documentation for compliance, completeness and data integrity.
• Issue laboratory notebooks and reviews and archives complete notebooks, assist with archiving of other documents
• Provide frontline QA oversight to lab-based / small-scale work (e.g., technical study execution, sample testing, sample distribution), either in-house or at third party suppliers.
• Perform data verification checks 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)

• Advise R&D on applicable requirements, deferring to more senior members in CRQA for complex issues
• Acquire and maintain knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets

• Identify and escalate risks to compliance to senior management
• Provides QA oversight and helps R&D use existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
• Support internal audits and helps prepare for regulatory inspections
• Support inspection finding responses related to applicable area of oversight
• Support the provision of accurate 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.
• 3-5+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.
• Previous work in a laboratory (in vitro 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