Description
Manager/Lead Software Quality Compliance/Validation
(Long-Term Contract)
Description
We are currently searching for two to three people that can fill Long-term Contract roles of Manager/Lead Computer System Validation and Compliance, located in Raritan, NJ.
We have secured several large long-term IT Regulatory Compliance Projects and we are responsible for key GxP compliance processes at our client. We need several Compliance Managers/CSV Project Managers/Senior Computer System Validation resources to help ensure our clients compliance with global GxP regulations and Quality Standards.
Software Quality Compliance/Validation
We need to add very Senior people to our team with strong Management, GxP, Computer System Validation (CSV) and Software Quality Compliance (SQC) backgrounds within FDA regulated environments.
We need individuals that can manage people, projects and compliance initiatives.
Some of the skills and experience that would be valuable would include: SAP, GxP, FDA Compliance, CSV, Documentation, HPQC - HP Quality Center Tools, Testing, CISA or ASQC Certification a plus - not required.
We need Senior experience, but people that can also roll up their sleeves if needed to assist with any related duties.
We are working on several large Applications that have been identified as having to undergo evaluation for remediation of GxP Compliance. Our teams will aid in gathering GxP Compliance Gaps in order to create a Complete Revalidation Package.
Tasks vary over multiple projects, but some upcoming tasks involved may include:
- Compliance Analysis & Plan
- User Requirements - System & Process
- Functional Specifications - FSD
- Technical Specification - TSD
- Configuration Document
- Traceability Matrix
- System Test Protocol/Scripts/Defects/Summary Report
- UAT Protocol/Scripts/Defects/Summary Report
- Traceability Matrix (Final)
- Compliance Summary Report
It is expected that the individuals will work collaboratively with the Client to implement specified Compliance; Process, Work Flows, Requirements, Validation; Testing; and Documentation tasks. Also, assist with various Testing, Test Script and Reporting tasks as directed by Client Management.
There are many phases to these projects and the assignment will go through 2014 and well into 2015. There is strong potential that this project will roll into other multi-year projects.
We are hoping to get some of the people on the team interviewed this week or next and start ASAP.
Qualifications
- A minimum of 10 years of quality, compliance experience is required for the Manager/Lead roles,
- 6+ years for Senior CSV roles.
- Experience within a global, FDA regulated healthcare industry is required.
- At least 5 years of experience within a GxP environment.
- Expert knowledge of Computer System Validation requirements, IT internal controls, Quality System Regulations, and experience with health authority auditing bodies is required.
- Strong experience in writing and managing compliance documents.
- Strong, demonstrated people leadership capabilities.
- Very strong communication skills, both verbal and written, at business and technical levels are required.
If you would like to be considered, please send a copy of your resume in Word format along with your contact information and convenient time to communicate.
E-mail resume