QMS System Implementation & Life Cycle Management at CSL Behring
King of Prussia, PA
About the Job
The Opportunity
Key Measures of Success
- Business Administration of QMS Platforms: System changes, internal and platform releases are well managed and status reports is provided anytime in a clear and easy understandable way.
- End-users / process owners/ power users / key users of QMS Platforms are well supported.
- Successful collaboration with all partners within and outside the quality organization such as IT and vendor.
- Helps ensuring a compliant validation status and the inspection readiness of QMS Platforms.
Key Tasks
- Coordinates meetings, communication with IT and Business to lead internal and platform releases on QMS platforms.
- Participates in projects on design, configuration, and validation.
- Supports end-users / process owners/ power users / key users of the QMS Platforms
- Update Quality Management System (QMS) procedures and work instructions related to QMS Platforms
- Executes periodic system tasks assigned to Business Administration for QMS platforms such as proxy clean-up, user review etc.
The Role
- Coordinates deployment and installation of technology assets to ensure agreement on our requirements and timelines.
- Executes technology lifecycle management strategy and platform enhancements, including policies, procedures, and best practice.
- Manages interface and communication across several functions to ensure high level of adoption for globally harmonized processes.
- Engages with enterprise-wide partners across IT and Business to lead internal and platform releases on those systems.
- Participate in projects related to QMS Platforms and integration efforts.
- Develop documentation related to technology assets to ensure reliability and compliance with company standards and regulatory requirements.
- Improve and optimization efforts to improve processes across departments.
- Design appropriate configuration on QMS Platforms and coordinates validation activities such as UAT, URS, PQ, regression testing etc.
- Supports end-users / process owners/ power users / key users of the QMS Platforms
Your Skills & Experience
Minimum Requirements
- Bachelor’s degree in computer science or related field.
- 5+ years' experience in pharmaceutical quality management in a cGMP environment.
- Experience working with QMS processes.
- Understand relevant standards of practice and regulatory requirements (e.g., FDA, EMA, and PIC/S).
- Demonstrated practical experience in IT application management considering GxP-compliance aspects like validation, qualification, and Data Integrity.
Preferred Requirements
- Lean six sigma/operational excellence qualifications/experience.
- Enhanced SME regarding Quality Applications (e.g. TrackWise, Veeva).
- Experience with computer systems, especially in Quality Management (preferably Pharma, Food or comparable).
About CSL Vifor
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
For more information, please visit viforpharma.com
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
