IT Compliance Lead
IT Compliance Lead
Accountable for delivering validation knowledge leadership for IT projects by creating computerized systems life cycle documentation, creating and revising IT standard operating procedures and deploying technology solutions to ease the administrative burden in a compliant manner.
- Develop solutions (knowledge base, artifacts, technology) to address IT Quality Compliance needs.
- Deliver agility to the organization by streamlining IT Change Management and CSV processes.
- Draft Computer Systems Validation and IT Change Management SOPs to align with GAMP 5 and industry standards.
- Author, review and update validation documents as necessary for GxP IT implementation projects.
- Provide Delivery Support to multiple ongoing IT initiatives.
- Evaluate business requirements and provide solutions based on need.
- Provide expertise in the areas of IT Quality & Compliance, Computer Systems Validation, Quality assessments, ISO 13485 regulations, 21 CFR Part 11, Annex 11, GxP requirements, Quality System Regulations, CAPA processes, Quality Management Systems design, Supply chain management, process validation and Quality system validation for regulated Life Science environments.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
- 7+ years of experience in Computer System Validation in a cGMP manufacturing environment.
- Knowledge of GMPs, GAMP 5, 21 CFR Part 11, Annex 11, MHRA/FDA Data Integrity
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.