Principal Cqv Consultant SME

Hi,

Please go through below requirement if you are comfortable; please share your updated resume to my email id: xxxxxxxxxxxxxxx

USC Visas are workable for this Position

Position: Principal CQV Consultant – SME

Location: Cary, NC (Remote)
Experience: 15+ Years | Pharma/Biotech

Note: Locals nearby or candidates who can work remotely but must be within driving distance of Cary, NC.

Seeking a CQV Subject Matter Expert to drive Business Development (Presales) and Delivery Oversight. This role combines solutioning, client engagement, and governance of CQV programs to ensure high-quality, audit-ready outcomes.

Key Responsibilities:

* Lead presales activities, client engagement, opportunity creation, and solutioning 

* Drive RFP/RFI responses, proposals, effort estimation, and delivery models 

* Build client relationships and support account growth (cross-sell/upsell) 

* Oversee CQV delivery (IQ/OQ/PQ, CSV/CSA, equipment, utilities, and facilities qualification) 

* Define risk-based validation strategies (ASTM E2500, GAMP 5, ICH Q9/Q10) 

* Ensure compliance with GxP, FDA, EMA, 21 CFR Part 11, Annex 11, Data Integrity (ALCOA+) 

* Review deliverables, manage risks, governance, and ensure audit readiness 

* Provide technical leadership, mentor teams, and support global delivery 

* Contribute to thought leadership, regulatory trends, and capability building 

Requirements:

* 15+ years in CQV/Validation with strong presales and leadership experience 

* Expertise in CQV, CSV/CSA, validation lifecycle, and data integrity 

* Strong stakeholder management, communication, and delivery governance skills 

* Experience with tools like Veeva, LIMS, MES, JIRA (preferred) 

KPIs:

* Presales win rate, pipeline growth, and proposal quality 

* On-time delivery, audit outcomes, and client satisfaction 

* Team development, reusable assets, and thought leadership contributions.