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sdlc data integrity gxp csv qms📋 Description
- Lead CSV/CSA strategy and governance for GxP systems.
- Ensure regulatory compliance and data integrity for digital systems.
- Partner with Quality, IT, Regulatory on system requirements.
- Oversee governance for validation, change control, deviations, CAPA.
- Lead Quality Management Review and cross-functional compliance forums.
- Enforce SDLC discipline and documentation quality across projects.
🎯 Requirements
- Bachelor's degree in a relevant scientific or technical discipline.
- 8+ years life sciences experience with strong GxP system expertise.
- Extensive leadership in cross-functional implementation and validation.
- Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training).
- Strong knowledge of global regulatory expectations and data integrity.
- Ability to lead enterprise programs, influence stakeholders, drive compliant decisions.
🎁 Benefits
- Remote work opportunities within the United States; some state restrictions apply.
- Travel to Cambridge, MA several times per year.
- Remote work setup with private, reliable internet access.
- Equal opportunity employer; accommodations available.
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