Principal CQV Consultant

Location: Cary, NC

**This position is not eligible for relocation assistance**
**This role is not eligible for Visa sponsorship**

Overview:

We are seeking a CQV Subject Matter Expert with a dual mandate: (1) Business Development / Pre‑Sales to shape opportunities, lead solutioning, and win new CQV programs; and (2) Delivery Oversight to govern execution quality, ensure audit-ready outcomes, and drive client satisfaction across qualification and validation engagements. The ideal candidate blends technical depth in CQV (risk-based qualification, data integrity, computerized systems validation/assurance) with strong client-facing leadership, commercial acumen, and the ability to work seamlessly with onsite and remote/global teams.

Responsibilities:
1. Business Development & Pre‑Sales

Opportunity Creation & Client Engagement

• Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients.
• Identify new qualification/validation opportunities across labs, manufacturing, QC, and QC IT landscapes.
• Identify opportunities in facility, utilities, and equipment qualification projects including cleanrooms, HVAC, compressed gases, water systems (PW/WFI), autoclaves, incubators, and environmental monitoring systems.
• Develop solutions and effort models for FAT/SAT support, commissioning, IQ/OQ/PQ, and performance verification of critical utilities. Lead requirement discovery sessions, customer workshops, and technical deep-dive meetings.
• Build trusted advisor relationships with client stakeholders.
• Engage early with prospects to qualify opportunities, discover needs, and shape CQV solution approaches (ASTM E2500, ISPE Baseline Guides, GAMP 5 2nd Ed., ICH Q9/Q10).
• Architect delivery models (onsite/offshore/hybrid), timelines, governance, and staffing plans.

Solutioning & Proposal Support

• Develop end‑to‑end CQV solutions, including efforts, delivery models, assumptions, and risk mitigation approaches.
• Lead RFP/RFI responses: write technical sections, define scope, assumptions, and deliverable lists; develop estimates/BOEs, and contribute to pricing and SOWs. Prepare technical content for RFPs/RFIs, capability decks, proposals, and executive summaries.
• Prepare and deliver client orals, capability briefings, demos, and case studies; tailor content to sponsor, QA, and IT stakeholders.
• Recommend delivery models (onsite/offshore/hybrid) based on project needs and site maturity. Support pricing strategies and effort estimation based on risk and compliance expectations.

Thought Leadership & Market Positioning

• Create thought leadership content: whitepapers, blogs, webinars, conference presentations on CQV best practices, data integrity, digital validation, Annex 1/Annex 11/21 CFR Part 11 readiness, etc.
• Represent the company at conferences, industry forums, and customer roadshows.
• Monitor regulatory trends and translate them into service offerings.

·       Collaborate with Marketing on thought leadership: white papers, webinars, conference talks (ISPE/PDA), and client workshops.

Account Growth & Enablement

·       Build executive relationships; identify cross-sell and upsell in adjacent areas (e.g., digital validation, audit trail review, data integrity remediation, lab system migrations).

·       Maintain a credible POV on CSA, Annex 11 alignment, AI/GenAI guardrails in GxP, and continuous monitoring of validated systems.

2. Delivery Oversight & Execution Support

Project Oversight

• Oversee qualification of analytical instruments, manufacturing equipment, and lab equipment. Provide SME oversight for ongoing CQV engagements (IQ/OQ/PQ, CSV, lab instrument qualification, analytical equipment qualification, facility & utilities qualification).
• Serve as engagement oversight lead: establish governance cadences, RAID management, and change control; ensure adherence to the client’s QMS and project stage gates
• Support project managers in ensuring scope alignment, risk management, and on-time delivery.

Technical Leadership

• Design risk-based qualification strategies for equipment, utilities, and facilities (URS, QRA, DQ/IQ/OQ/PQ/PPQ), and CSV to CSA approaches for lab/manufacturing systems (21 CFR Part 11, Annex 11, Data Integrity/ALCOA+).
• Advise and guide onsite/remote validation consultants on qualification strategy, deviations, test design, and documentation quality.
• Troubleshoot technical issues and escalate risks proactively to both internal teams and clients.
• Review and approve critical deliverables such as validation plans, test protocols, summary reports, traceability matrices, and risk assessments.
• Ensure alignment with GxP, data integrity guidelines, FDA, EMA, WHO, and ICH expectations.
• Provide technical QA on key deliverables (URS, QRA, protocols, summary reports, traceability matrices, validation plans/reports).
• Ensure audit readiness and defend validation approach in internal/external audits (e.g., FDA, EMA).

Team Collaboration & Quality Governance

• Work seamlessly with global teams across timelines and cultural contexts.
• Establish standardized templates, best practices, and checklists across CQV projects.
• Drive continuous improvement in delivery methodology, validation approaches, and documentation quality.
• Direct blended teams (onsite/remote/offshore); set clear objectives, templates/standards, and working agreements.
• Coach project leads/consultants; resolve technical blockers; ensure consistent application of risk-based practices and right-sizing documentation.
• Monitor scope, schedule, cost, and client satisfaction; drive issue resolution and continuous improvement.

Stakeholder Management

·       Interface with client such as QA, CQV, MS&T, Manufacturing, IT/CSV, and business functions (Clinical, Quality, Supply).

·       Communicate status and risks effectively to executive sponsors; align priorities and success criteria.

3. Internal Enablement & Capability Building

• Mentor validation engineers, team leads, and junior SMEs.
• Support internal training initiatives on CQV trends, tools, and regulatory expectations.
• Contribute to solution accelerators, reusable templates, and playbooks.
• Strengthen collaboration between BD, delivery, and practice leadership teams.