Senior Data Integrity Consultant (GxP)
- Perform requalification of existing computer systems and support periodic reviews to maintain a validated state.
- Lead and execute: Periodic System Reviews (PSR): Evaluating the ongoing "state of control" and effectiveness of the system's data lifecycle, User Account Reviews (UAR): Ensuring strict segregation of duties and appropriate GxP access levels.
- Drive the enhancement of Quality Compliance operating procedures to bridge gaps between local manufacturing standards and global quality expectations.
- Interface between local site manufacturing quality standards and global standards to ensure a unified compliance posture.
Senior Data Integrity Consultant (GxP) Qualifications:
- 8+ years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred), with a focus on Data Integrity, Computer System Validation, and Quality Compliance.
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
- Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820, EU EudraLex Volume 4 (Annex 11 and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data governance frameworks
- Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.
- Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
- Hands-on experience with Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), and laboratory/manufacturing systems..
- Experience developing training materials and delivering training to employees on DI and CSV topics.
- Ability to lift up to 20 pounds as needed.
Shift:
- Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.
#PP
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