About OnShore Technology Group, Inc.
For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.
OnShore’s leading innovation is ValidationMaster™, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.
Sr. Validation Lead
LOCATION:
Chicago, Illinois, USA
ABOUT THE POSITION
The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.
ROLES & RESPONSIBILITIES
- Ability to lead and coordinate multiple CSV projects
- Develop / review validation test protocols as required using automated technology tools
- Coordinate / communicate with other departments, SMEs
- Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
- Create, track and manage all validation project plans
- Provide regulatory guidance on principles of CSV to the expanded team
EDUCATION & CERTIFICATION
- B.S. or equivalent in computer science, engineering, life sciences, or related field
- Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role
- ASQ CSQE Certification or equivalent preferred
- Practical working knowledge of software development and implementation methodologies
- Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
- Strong oral and written communication skills in English.
- Excellent interpersonal skills.
- Advanced skills at team management, organization, and communication of priorities and listening
- Practical experience in conducting and supporting CSV audits and inspections.
- Advanced proficiency in the use of Microsoft Office desktop applications
REGULATORY KNOWLEDGE REQUIREMENTS
- ISPE GAMP 5®
- U.S. FDA Validation Guidance Document
- 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
- U.S. FDA Data Integrity Guidance
- NIST Cybersecurity Framework
- 21 CFR Part 210/211 cGMP
- EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4
- 21 CFR 820 Quality System Regulations
- 21 CFR 820.30 Design Controls
- Other regulations as applicable