Principal CQV Consultant (CQV SME)- W2

Role: Principal CQV Consultant (CQV SME)
Location: Cary, NC(Hybrid-Need to attend Client meetings)
Exp:10+
Duration: Long Term
Employment: W2

Seeking a CQV Subject Matter Expert with a dual mandate (1) Business Development / Presales 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 & Presales

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
Requirements

Qualifications
Bachelor's or master's in engineering, Life Sciences, Pharmacy, or related field
10-15 years in CQV/Validation within pharma/biotech (at least 5 years in client-facing leadership or program oversight). Demonstrated presales experience is required
Technical Depth (examples){{:}}
CQV ASTM E2500, ISPE Baseline Guides, ICH Q9/Q10, risk-based qualification, FAT/SAT, DQ/IQ/OQ/PQ/PPQ, cleaning validation basics, utilities (WFI/PW/HVAC), and facility/equipment commissioning
CSV/CSA 21 CFR Part 11, EU Annex 11, GAMP 5 (2nd Edition), Data Integrity (ALCOA+), risk-based testing, supplier assessment, periodic review, and continuous verification/monitoring
Laboratory & Enterprise Systems (nice-to-have)QMS (e.g. Veeva Quality Suite), LIMS, CDS (e.g., OpenLab, Chromeleon, Empower), LES/ELN, MES, DMS etc.
Core Skills Solutioning and scoping; proposal writing; stakeholder management; delivery governance; risk management; excellent written and verbal communication; coaching and team leadership
Tools/Methods Proficiency with validation lifecycle tools, test management, requirements traceability, and standard documentation toolsets (e.g., Veeva Vault QMS/DMS, JIRA, Confluence, MS Project)

Key Performance Indicators (KPIs)
BD/Presales Win rate; qualified pipeline generated; proposal quality and cycle time; account growth; CSAT during orals/POCs
Delivery Oversight On-time/on-budget delivery; audit/inspection outcomes; defect escape rates; change control efficacy; stakeholder satisfaction (NPS/CSAT)
Leadership & Impact Adoption of risk-based practices; reusables/accelerators created; mentor feedback; retention and engagement of team members
Thought Leadership Number/quality of publications, webinars, conference talks; client workshops delivered; internal enablement sessions

Travel & Work Model
Ability to travel (~20-40%, variable) for client workshops, site commissioning/qualification, and executive reviews. Comfortable leading hybrid delivery with remote/offshore teams