Veeva Quality Management Systems Consultant
Hawkins Point Partners, United States
Job Description
Hawkins Point Partners is looking for a Veeva QMS Analyst to join their team immediately. This resource will partner with the Quality function to collect, clarify, and translate business requirements into documentation and conceptual design to enable system implementation and support. They will shape the system/ IT demand from the Quality functions by gaining insights into business processes and developing mitigation options.
Requirements
o Partner with the Quality stakeholders and product vendors to elicit, analyze, translate, and document business requirements into technical/ system requirements
o Draft business requirements, functional requirements, system/ technical requirements and system integration test (SIT) and Unit Acceptance Test (UAT) plans
o Analyze, document and test program development, logic, process flows and specifications
o Develop user test cases, conduct user testing and monitor implementation for new systems, bug fixes and enhancements
o Partner with the business teams to conduct user acceptance testing and gain solution sign-off
o Document user manuals to describe application usage by the user community and operating procedures
o Coordinate the project resources to ensure that projects are delivered on time and within budget
o Lead and perform validation activities for new implementations and ongoing maintenance
o Draft/ update SOPs and templates for Computer Systems Validation (CSV)
Qualifications
- Minimum ten years of IT and/or Ramp;D and Quality operations experience; biotech or life sciences industry experience mandatory
- Minimum five years of experience implementing and supporting solutions for quality, clinical operations, and regulatory affairs
- Minimum two years of implementation experience with Veeva Vault QualityDocs and Training modules
- Thorough understanding of clinical trial management, regulatory operations and computer systems validation (CSV) processes
- Minimum three years of experience in project management
- At least 5 full lifecycle project implementation experience
- Demonstrated experience in writing software requirements and test specifications
- Experience working on global or regional projects with team members in multiple locations
- Expertise developing/ maintaining Software Development Life Cycle (SDLC) policies and procedures in a CFR Part 11 or equivalent environment
Education
- Bachelor’s degree in a related field such as computer science, pharmaceutical science, biochemistry, chemistry and health sciences
- Master’s degree preferred
- Training and/or certifications in Clinical Trial Management, Regulatory Operations and CFR Part 11 preferred
- Project Management or Six Sigma or other process certifications preferred
Benefits
At Hawkins Point Partners we believe in creating great experiences for our colleagues. We offer competitive compensation along with comprehensive benefit options to meet the diverse needs of our colleagues in their personal and professional lives.