
Data Integrity Leader
6 days ago
We are seeking an experienced Senior Quality Assurance Manager to lead our site data integrity initiatives. The ideal candidate will oversee quality governance for electronic and computerized systems, implement data integrity and computer system validation processes, and manage the validation lifecycle.
Key Responsibilities:
- Oversight of quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP)
- Implementation of data integrity and computer system validation (CSV) processes
- Management of validation lifecycle, change control, deviations, and CAPAs
- Support for regulatory inspections and maintenance of inspection readiness
- Drive continuous improvement and contribute to global quality strategies
Requirements:
- Bachelor's or higher in Science, Engineering, Computer Science, or related field
- 10+ years of experience in quality/compliance within biopharma or biotech environments
- Strong understanding of GMP, CSV (GAMP 5), and global data integrity regulations (e.g., 21 CFR Part 11, Annex 11)
- Proficiency with lab and manufacturing systems, and validation tools
- Excellent leadership, communication, and cross-functional collaboration skills
What We Offer:
A challenging role with opportunities for growth and development in a dynamic organization.
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