Job Description:
- Consultant Pharmaceutical QMS GxP
- We are seeking a highly experienced IT Consultant 10 years to lead the design and implementation of Quality Management Systems QMS in GxP regulated pharmaceutical environments
- This role combines deep expertise in business analysis and eQMS implementation with strong advisory capabilities in process harmonization and regulatory compliance
- As a key member of our Life Sciences R D consulting team you will play a pivotal role in delivering scalable compliant QMS solutions
- You ll lead quality initiatives facilitate cross functional workshops and help shape global quality processes aligned with regulatory standards such as ICH FDA EMA MHRA and ISO 9001
Key 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
Technical 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
Additional Responsibilities:
- A degree in a technical scientific or clinical discipline is preferred
Preferred Skills:
Technology->Life Sciences->CTMS/Trial conduct
