Senior Life Science Quality Assurance Specialist

About the role

The Life Science Quality Assurance Specialist III is a senior‑level professional reporting to the Life Science Quality Manager. The role leads quality systems, facilitates stakeholder meetings, provides data tracking and trending, and drives continuous improvement across the organization.

Key responsibilities

• Own and maintain Quality System processes including event reporting, document control, supplier qualification, validations, and product transfer.
• Facilitate cross‑functional meetings and provide data analysis for tracking and trending quality metrics.
• Lead quality and continuous improvement initiatives, including CAPA and change management.
• Train and mentor the organization and new Quality Team members on Quality Systems.
• Partner with stakeholders to enhance the quality program and culture, and remediate risks for internal and external customers.

Required profile

• Senior‑level experience in life‑science quality assurance.
• Proven ability to lead quality system implementation and improvement.
• Experience training and mentoring staff on quality processes.
• Strong communication and stakeholder management skills.
• Ability to drive change and mitigate risks.

Required skills

• Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint)
• Document Control Program management
• Supplier Qualification processes
• Validation activities
• Product Transfer procedures