Quality Systems Manager – Dublin Contractor

This is a 12 month contract. 

Responsibilities:

• Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure and monitoring of deviations, investigations, CAPAs, change controls.
• Collaborate with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS.
• Proactively identify and communicate risks, issues, and best practices within the QMS.
• Establish new and improve existing forums for performance monitoring and end user support.
• Create and update QMS procedural documentations and work instructions with accuracy and clarity.
• Create and deliver QMS training (process and technical).
• Participate in inspection readiness activities, self-inspections of the QMS and external audits.
• Other duties as required to support the growing Quality organization.

Minimum Qualifications and Experience: 

• Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
• 12 years’ + experience in Quality Systems within the pharmaceutical industry.
• Prior experience in a global QA role at the management level
• Demonstrated critical thinking and problem-solving skills.
• Knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems.
• Direct experience with development and approval of deviations, CAPAs and Change Controls.
• Prior experience in project planning and leadership within a matrix environment.
• Prior experience training and coaching for skill development.
• Excellent written and verbal communication skills.
• Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
• Direct experience with TrackWise desired.