Validation Lead
Posted 2 weeks ago by 1754715297
Negotiable
Outside
Remote
USA
Summary: The Validation Lead role involves overseeing testing and validation for medium to large system implementations, ensuring compliance with GxP standards. The position requires extensive experience in various methodologies and proficiency in project management tools. The candidate should have a strong understanding of regulatory guidelines and the ability to manage multiple projects across time zones. Experience in the Life Sciences or Pharma industry is preferred.
Key Responsibilities:
- Lead testing and validation efforts for system implementations, ensuring GxP compliance.
- Guide teams using Waterfall, Iterative, and Agile methodologies to achieve project outcomes.
- Utilize Microsoft Office Suite and HP ALM for project management and reporting.
- Manage testing cycles and maintain broad technical knowledge of SaaS and Cloud systems.
- Adapt to working across time zones and manage multiple projects effectively.
Key Skills:
- Proven leadership in testing/validation for system implementations.
- Experience with SaaS and Cloud systems in a GxP environment.
- Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines.
- Proficiency with HP ALM and project management methodologies.
- Excellent communication skills, both verbal and written.
- Adaptability to new technologies and workflows.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Detailed Description From Employer:
Client: WinWire
on C2C/ submit below 20 years resource
Job Title: Validation Lead
Location: Fully remote contract
Duration: Long term contract
Educational Qualification*
BE, Comp Science, BCA, BSE computer science
Job Description of Role* (RNR)
(Mandatory - Minimum 500 words)
(Mandatory - Minimum 500 words)
Proven leadership in testing/validation for medium to large system implementations, ensuring GxP compliance and quality delivery.
Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes.
Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting.
Expertise in HP ALM for managing testing cycles, with broad technical knowledge of SaaS and Cloud systems in a GxP environment.
Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing.
Flexibility to work across time zones, manage multiple projects, and travel as needed, with Life Sciences or Pharma experience preferred.
Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes.
Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting.
Expertise in HP ALM for managing testing cycles, with broad technical knowledge of SaaS and Cloud systems in a GxP environment.
Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing.
Flexibility to work across time zones, manage multiple projects, and travel as needed, with Life Sciences or Pharma experience preferred.
Primary (Must have skills)*
Testing/Validation for System Implementations:
CSV
Knowledge and prior experience in testing and validation for medium to large system implementations.
Experience in working with SaaS and Cloud systems in a GxP environment.
Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines.
Proficiency with HP ALM (Application Lifecycle Management).
Methodologies:
Experience with Waterfall, Iterative, and Agile methodologies.
CSV
Knowledge and prior experience in testing and validation for medium to large system implementations.
Experience in working with SaaS and Cloud systems in a GxP environment.
Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines.
Proficiency with HP ALM (Application Lifecycle Management).
Methodologies:
Experience with Waterfall, Iterative, and Agile methodologies.
Expierence Range
Secondary Skills (Good To have)*
Industry-specific Experience:
Experience and education in Life Sciences or Pharma preferred.
Experience and education in Life Sciences or Pharma preferred.
Soft skills/other skills (If any)
Adaptability: Ability to quickly adjust to new technologies, workflows, and environments.
Communication: Excellent communication skills, both verbal and written.
Flexibility to work in different time zone hours and travel as required.
Communication: Excellent communication skills, both verbal and written.
Flexibility to work in different time zone hours and travel as required.