About the job
Location: Cary, NC
**This position is not eligible for relocation assistance**
**This role is not eligible for Visa sponsorship**
Overview:
Join our team at Zifo Technologies as a Principal CQV Consultant, where you'll serve as a CQV Subject Matter Expert with a unique focus on both Business Development and Delivery Oversight. You will engage with clients in the pharmaceutical and biotech sectors, shaping opportunities, leading solutions, and ensuring high-quality execution of qualification and validation engagements. The ideal candidate will possess a deep technical understanding of CQV principles, including risk-based qualification, data integrity, and computerized systems validation, alongside robust client-facing leadership and commercial insight.
Key Responsibilities:
1. Business Development & Pre‑Sales
Opportunity Creation & Client Engagement
- Serve as the primary CQV SME during pre-sales interactions with pharmaceutical and biotech clients.
- Uncover new qualification and validation opportunities across laboratories, manufacturing, QC, and QC IT environments.
- Identify potential projects in facility and utilities qualification, including cleanrooms, HVAC systems, and environmental monitoring systems.
- Engage in requirement discovery sessions and technical workshops to develop tailored solutions for FAT/SAT support, commissioning, and performance verification.
- Foster trusted advisor relationships with client stakeholders.
- Participate in early-stage discussions to qualify opportunities and tailor CQV solutions according to established guidelines (ASTM E2500, ISPE Baseline Guides, GAMP 5 2nd Ed., ICH Q9/Q10).
- Design delivery models (onsite/offshore/hybrid) and develop effective governance and staffing plans.
Solutioning & Proposal Support
- Create comprehensive CQV solutions, including effort models, delivery frameworks, and risk mitigation strategies.
- Lead responses to RFPs/RFIs by drafting technical content, defining scope, and developing project estimates and pricing.
- Prepare and deliver engaging client presentations, capability briefings, and demonstrations tailored to various stakeholders.
- Advise on optimal delivery models based on project requirements and client needs.
Thought Leadership & Market Positioning
- Contribute to our thought leadership initiatives by developing content such as whitepapers, blogs, webinars, and conference presentations focused on CQV best practices and industry standards.
