Title: Sr. Computer Systems Validation Lead
Location: South San Francisco
Type of role: Contract 1-2+ year’s
The Sr. Computer System Validation (CSV) lead is responsible for providing guidance on GxP system validation activities and ensuring computer systems follow applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This role is also responsible for the development of Standard Operating Procedures (SOPs) and templates specifically related to software validation and testing. Duties include overseeing and executing the validation of new systems; evaluating and performing periodic reviews of existing validated computer systems to ensure / verify continued compliance with appropriate regulations and maintaining required change control procedures. The Sr. CSV consultant will develop design and test documentation including user requirements, risk assessments (RA), test plans, Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification (DQ/IQ/OQ/PQ) tests and validation summary reports.
- Draft IT computerized system validation (CSV) policies and SOP's, obtaining guidance from Information Technology and applicable department leads
- Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to: Validation Plans, Risk Assessments, Project Plans, User/Functional Requirement/Design/Configuration Specifications, Qualification Protocols, Final Report, Change Controls, Periodic Reviews.
- Lead risk assessments to determine testing strategies and scope for automation related projects and changes.
- Work with internal and external customers to identify and implement improvements within the Technology department related to system development lifecycle (SDLC) and change management business processes.
- Represent IT in audits, investigations and discrepancy resolution.
- Participates on cross-functional teams dedicated to process improvement, efficiency and optimization.
- Participates on cross-functional teams aimed at defining best practices and improving process performance.
- Foster teamwork and drive project/process improvements.
- Communicates proactively with stakeholders and management regarding progress, issues, and plans for resolution.
- Expected to participate in cross-functional projects or teams in support of mission
- 8+ years of experience in the Pharmaceutical or Biotech industry Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11 following GAMP concepts.
- Must have profound knowledge of the FDA, EMEA and International regulations regarding Computer Systems.
- Knowledge of CSV requirements and procedures (IQ/OQ/PQ) for on-premise and SaaS solutions.
- Knowledgeable of FDA, GxP, EMEA and International related regulations and guidelines such as GAMP and ICH and ISO. Specific knowledge of computer validation methodologies and principles is a must
- Working, hands-on, knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
- Strong organizational, communication (written and oral), and interpersonal skills. Team oriented, dependable, self-starter.
- Must have strong leadership, negotiation and presentation skills.
- Ability to work independently, attention to detail, maintain accurate records, follow instructions, and comply with company policies.