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Principal CQV Consultant

Zifo TechnologiesCary, North Carolina, United States
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

To be successful in this role, candidates should possess:A deep understanding of CQV processes and regulatory requirements. Experience in business development and client engagement within the pharmaceutical or biotech industries. Strong leadership abilities and excellent communication skills. Proven track record in developing and executing CQV solutions. Ability to work effectively with both onsite and remote teams.

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.

About Zifo Technologies

Zifo Technologies is a leading provider of integrated services for the life sciences industry, specializing in delivering innovative solutions that streamline processes and enhance compliance. Our commitment to quality and client satisfaction drives our success across various sectors, including pharmaceuticals and biotechnology.

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