Program Quality Manager - Basel - 6 months
- Vivid Resourcing Ltd
A global pharmaceutical client of mine are currently looking for a Program Manager (Quality) to join them on a Contract Basis for an initial 6 months based at their site in Basel, Switzerland. Work is set to commence toward the end of January.
- Well Versed in Computer system validation and strong Project Quality management experience
- Building Validation and Compliance strategy for IOT (Internet of things) Platforms
- Hands-on experience in managing large programs (from a QM perspective) and be familiar with Global drug development (GDD)/Drug Development life cycle (DDLC) general processes
- Hands on experience building Validation and Compliance strategy for software as Medical device (SaMD)
- Be able to interact with senior leadership team
- Collaboration and driving quality & validation alignment with e-Compliance (IT QA), and Business and Functional QA, Supplier etc.
- Be familiar with Agile in Computer System Validation process
- Authors Program/Project validation documents, following up the entire review process
- Supports the Project Manager throughout the project delivery from project planning through execution
- Ensures training completion of all program team members
- Coaches and supports the project team in fulfilling the requirements of the project and custodian of the overall validation methodology
- Accountable, together with the Project Manager, for the creation, review and approval of program/project and system life cycle documentation as per defined RACI
- Ensures all deviations from both processes and system perspective are resolved or placed into approved remediation plans
- Defines and drives change control
- Responsible for the tollgates review schedule as planned for program and projects
- Ensures that applicable ISRM and Data Privacy standards and requirements are fulfilled or followed within the project
- Ensures that all test execution documentation is complete and properly recorded and in particular that a complete Traceability Matrix and Validation Report have been prepared for approval
- Approves all test execution documents
- Ensures that all validation relevant documents are stored appropriately for future audit reference
- Stakeholder Management with BISM/BISE/eCPL/IT Compliance
Job Type: Contract
Duration: 6 months
Location: Basel, Switzerland
Rate: Negotiable (DOE)
If you are interested in this role or know anyone who might be please forward your most up to date CV ASAP and I will be in touch to discuss further. Alternatively you can give me a call to find out more.
*As always Referrals are much appreciated*
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.