- Company Name
- Consultant Specialists, Inc. (CSI)
- Job Title
- Senior Data Integrity Consultant
- Job Description
-
**Job Title:** Senior Data Integrity Consultant (GxP)
**Role Summary:**
Seasoned consultant responsible for leading and advancing the Data Integrity program across laboratory, manufacturing, and quality systems. Ensures data reliability, regulatory compliance, and audit readiness in a biotech/pharma environment.
**Expectations:**
- Lead DI strategy and remediation.
- Maintain compliance with FDA, EU, and industry standards.
- Provide QA oversight for computerized and paper‑based GxP records.
- Communicate effectively with cross‑functional teams and senior leadership.
**Key Responsibilities:**
- Design, implement, and continuously improve the site’s Data Integrity framework.
- Conduct gap assessments, develop remediation plans, and track execution.
- Ensure adherence to 21 CFR Part 11/210/211/820, EU Annex 11, GAMP 5, and ALCOA+ principles.
- Review and approve validation documentation (URS, RA, IQ/OQ/PQ, VSR, PSR).
- Support audit and inspection activities; maintain inspection readiness.
- Oversee system lifecycle governance and QMS processes (Change Control, Deviations, CAPA, Document Control, Training).
- Collaborate with technical SMEs to enhance data flow, security, and integration controls.
- Provide guidance on EDMS, LMS, and laboratory/manufacturing system usage.
**Required Skills:**
- Deep expertise in Data Integrity, Computerized System Validation, and GxP quality compliance.
- Strong knowledge of QMS processes and regulatory requirements (FDA, EU).
- Proficiency with Electronic Document Management Systems, Learning Management Systems, and lab/manufacturing software.
- Excellent written and verbal communication; ability to lead complex compliance initiatives.
- Analytical problem‑solving and project‑management capabilities.
**Required Education & Certifications:**
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related discipline.
- Minimum 8 years experience in a GxP-regulated environment (biotech/pharma/cell & gene therapy preferred).
- Relevant certifications (e.g., Certified Quality Auditor, GAMP Practitioner) are advantageous but not mandatory.