What are the responsibilities and job description for the Project Manager position at KPG99 INC?
Job Title:Project Manager (Business Systems / GxP Environment)
Location:Lexington, MA (5 Days Onsite)
Local Candidates Only
Duration: 6-Month Contract
Required Qualifications:
- 5–7 years of experience as a Project Manager, Business Analyst, or hybrid PM/BA
- Experience working in GxP-regulated environments (GMP, GLP, GxP)
- Strong understanding of:
- Computerized System Validation (CSV)
- Change Control
- Compliance Documentation
- Proven experience leading or supporting:
- Process improvement initiatives
- Current-state and future-state process mapping
- Business requirements gathering and documentation
- Roadmap development
- Experience coordinating with external vendors and/or managed service providers during system implementation, migration, or configuration projects
- Excellent stakeholder management skills with the ability to collaborate across business and technical teams
- Experience supporting Manufacturing, Quality, or Regulatory Operations (not Clinical Operations)
- Ability to balance both project management and business analysis responsibilities across multiple initiatives
- Excellent written and verbal communication skills with strong documentation abilities
Preferred Qualifications:
- Experience with Veeva Vault
- Experience with Regulatory Information Management (RIM) systems
- Experience with Quality Management Systems (QMS)
- Background in Life Sciences, Biotechnology, or Pharmaceutical Manufacturing
- Familiarity with GAMP 5 risk-based validation methodology
- Open to a potential contract-to-hire opportunity