
Senior Quality Assurance Manager: Data Integrity Specialist
11 hours ago
Our client is a global biopharmaceutical manufacturer seeking an experienced Associate Director to lead site data integrity efforts.
Data Governance- Oversight of quality governance for electronic and computerized systems, including MES, Delta V, LIMS, ELN, SAP.
- Lead implementation of data integrity and computer system validation processes.
- Manage the validation lifecycle, change control, deviations, and CAPAs.
- SUPPORT regulatory inspections and maintain inspection readiness.
- Drive continuous improvement and contribute to global quality strategies.
- Train and mentor staff in data integrity and CSV best practices.
Requirements:
- Bachelor's or higher degree 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, including 21 CFR Part 11, Annex 11.
- Proficiency with lab and manufacturing systems, and validation tools.
- Excellent leadership, communication, and cross-functional collaboration skills.
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