A Biotechnology company in NJ is currently seeking a CSV/Veeva QMS Lead to join their team on a remote capacity.
Position Summary
Computerized Systems Validation Lead/Veeva QMS
This position is primarily responsible for providing oversight to ensure company computerized systems are deployed following life-cycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements. Position will provide QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), Veeva QMS (electronic Quality Management System), and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Serve as QA electronic system validation expert and will provide oversight and guidance on computer systems validation in accordance with applicable regulations, guidelines, policies and procedures.
- Train, support and advise end users on EDMS and QMS system requirements and workflows.
- Manage the GMP document life-cycle management process, which includes, providing guidance, formatting, content, management, archival, and retrieval of documents.
- Manage periodic reviews of procedural documents and Document Change Control Programs.
- Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
- Act as Quality liaison for business integration and new product initiatives. This includes QA support such as audits, training curriculum, quality agreements, QA record reviews (SOPs, batch records, deviations, CAPA, etc.).
- Tracking and trending of performance against quality metrics.
- Provide support during regulatory inspections and internal audits.
Requirements
- Experience with Veeva systems is preferred.
- Experience implementing, validating, maintaining and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.
- Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation and quality management tools.
- Education - BS Degree required or preferred
- Experience as QA reviewer of several GMP records: Audits, Quality Agreements, Validation Protocols, Deviations, CAPA, SOPs, etc.
- Must have excellent communication skills (verbal and written).
- Demonstrate ability to manage projects and variable workloads.
- Highly organized with a strong attention to details, clarity, accuracy, and conciseness.
