Position: The Quality Systems Validation and Compliance Lead/Principal
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
The Quality Systems Validation and Compliance Lead/Principal is a newly developed role who will be responsible for building, implementing and managing the GxP Computer Systems Validation program at Karyopharm. As a critical member of the Quality Management Systems team, this role will help build and improve the processes for Computer Systems Validation and system change management. This position reports to the Associate Director of Quality Management Systems. This is an individual contributor role, but may include managing consultants and contractors for various CSV projects.
- Design and implement the GxP Computer Systems Validation program at Karyopharm, to help centralize oversight of GxP computer systems
- Provide computer validation support as the Quality SME for computer system assessments, validation and system change control, and provide effective Quality support at all stages of the computer systems lifecycle.
- Ensure Quality & Compliance requirements are considered in any computer system change initiative or GxP change request.
- Draft, review or approve (depending on authorship) validation documentation such as SOPs, Master Validation Plans, Traceability Matrices, testing deliverables, and data migration plans for GxP computer systems.
- Proactively provide suggestions for solutions to validation process issues, and collaborate with appropriate stakeholders to drive towards execution of solutions.
- Provide timely updates on CSV projects and deliverables to Quality Management Systems and senior leadership.
- Work in collaboration with GxP Computer Systems Vendor Management to support CSV audits.
- Bachelors’ degree with at least 8-10 years’ experience in computerized system validation projects
- Proven experience in managing the Quality aspect of validation projects
- Effective communication and interpersonal skills to influence and resolve conflict
- Authoring clear and effective SOPs, WIs and training aids
- In-depth knowledge of quality systems principles (e.g. Change Management, Deviations / CAPA) and applications to the pharmaceutical industry
- Ability to identify and clarify complex problems and constructively provide potential solutions
- Knowledge of GxPs, ICH, and GAMP Guidance
- Familiarity with virtualization and cloud models in the pharmaceutical industry
- Audit experience in Quality Systems and SDLC
- Experience in both R&D and Commercial Pharmaceutical settings
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