Use deep process knowledge and experience to assist business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems.
On-time completion of assigned projects.
Monitor QMS process performance to identify trends and best practices on an ongoing basis (audits, visual management systems, dashboards, status reports etc.).
Author, review and approve of QMS procedural documentation and work instructions.
Create and deliver Quality Systems training (process and technical).
Compile, analyze and present QMS monthly and quarterly metrics at Quality Management Review.
System user access management.
Participate in inspection readiness activities and internal/external audits and inspections.
Other duties required to support the growing Quality organization as assigned.
5 years’ + QA experience within the pharmaceutical industry or related field.
Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments.
In-depth knowledge of global cGxP requirements for quality systems.
Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions.
Excellent communication skills with all levels of the organization and Health Authority representatives.
Demonstrated critical thinking and problem solving skills.
High level of organization and attention to detail to plan, execute and track completion of deliverables.
Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
Knowledge of medical device quality system requirements desired.
Direct experience with TrackWise desired.
Project Management and Lean Six Sigma certifications a plus.