Digital Quality Manager Quality Systems CSL Seqirus Maidenhead, Berkshire, United Kingdom R-286010 Posted on September 24, 2026 in Thatcham

Responsibilities:

• Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines

• Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)

• Participates in project teams to provide review and approval of project Validationdocumentation according to applicable approval matrix or procedures

• Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management

• Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained

• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects

• Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics

• Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems

• Collaborates to resolve technical issues, provide quality training and communicate best practices

Qualifications:

• Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience

• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment

• Knowledge of current Good Manufacturing Practices (cGMP)

• Knowledge of FDA and EMA requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.