Responsibilities :
Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compliant QMS frameworks tailored to client needs. Collaborate with cross-functional teams to gather and document requirements across functional, migration, and integration workstreams. Translate business needs into functional specifications using tools like JIRA and HP ALM. Implement and support supplier qualification, audits, performance monitoring, and risk management processes. Integrate supplier quality workflows into enterprise QMS platforms.Lead workshops to assess current QMS maturity and define future-state processes. Design scalable, GxP-compliant QMS frameworks tailored to client needs. Collaborate with cross-functional teams to gather and document requirements across functional, migration, and integration workstreams. Translate business needs into functional specifications using tools like JIRA and HP ALM. Implement and support supplier qualification, audits, performance monitoring, and risk management processes. Integrate supplier quality workflows into enterprise QMS platforms.
Additional Responsibilities:
A degree in a technical, scientific, or clinical discipline is preferred.
Technical and Professional Requirements:
Proven experience in eQMS design and implementation within GxP-regulated environments. In-depth knowledge of QMS processes such as- supplier quality, audit processes, risk management, change control, deviation, complaints, etc. Hands-on experience with leading QMS tools such as Veeva Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl. Strong background in business analysis, stakeholder engagement, and regulatory compliance. Excellent communication, facilitation, and project management skills. Ability to work both independently and collaboratively across global teams.
