Note: The job is a remote job and is open to candidates in USA. CAI is a 100% employee-owned professional services company that provides consulting services associated with operational readiness and operational excellence to FDA-regulated industries. The Operational Readiness Project Manager will lead project teams, manage client engagements, and ensure successful delivery of readiness programs while fostering a culture of continuous improvement.
Responsibilities
- Lead project teams to achieve Operational Readiness (OR) objectives
- Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously
- Drive on-time, on-scope delivery of readiness programs
- Serve as the primary consultant for OR campaigns integrating with Quality, Process, and Workforce streams
- Apply OE principles to pre-Day One activities (e.g., visual management, accountability, problem-solving)
- Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.)
- Guide decision-making with a risk-based, speed-to-value mindset
- Lead and coach cross-functional teams including CQV, Quality, and external contractors
- Cultivate a culture of feedback and growth
- Contribute to CAI's brand via white papers, conference presentations, and client tools
Skills
- BS or MS in a relevant science or engineering field (or equivalent)
- 3+ years as a program/project manager on life science projects ($1MM+), or 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/OE transformations
- Proven multi-site or multi-client portfolio experience
- Deep understanding of quality systems, tech transfer, equipment qualification, and analytics
- Excellent communication, leadership, and stakeholder management skills
- Proficient in project management software tools
- Excellent written and verbal English communication
- Able to work in the U.S. without sponsorship now or in the future
- Domestic and international travel may be required
- Willing to work overtime when necessary
- (Black Belt or equivalent preferred.)
- PMI PMP or PgMP certification a plus
Education Requirements
- BS or MS in a relevant science or engineering field (or equivalent).
Benefits
- Comprehensive Health Insurance coverage
- 24 days of Paid Time Off
- ESOP/401K - 15% Company Contribution (US Only)
- Company paid Life Insurance
- Company paid Long Term Disability
Company Overview
CAI is a consulting company that provides technical, operational consulting, and project management services. It was founded in 1996, and is headquartered in Indianapolis, Indiana, USA, with a workforce of 501-1000 employees. Its website is https://cagents.com/.