Principal CQV Consultant

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.ResponsibilitiesBusiness Development & Pre?SalesOpportunity Creation & Client EngagementAct as the primary CQV SME during pre-sales discussions with pharma/biotech clientsIdentify new qualification/validation opportunities across labs, manufacturing, QC, and QC IT landscapesIdentify opportunities in facility, utilities, and equipment qualification projects including cleanrooms, HVAC, compressed gases, water systems (PW/WFI), autoclaves, incubators, and environmental monitoring systemsDevelop 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 meetingsBuild trusted advisor relationships with client stakeholdersEngage 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 plansDevelop end-to-end CQV solutions, including efforts, delivery models, assumptions, and risk mitigation approachesLead 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 summariesPrepare and deliver client orals, capability briefings, demos, and case studies; tailor content to sponsor, QA, and IT stakeholdersRecommend delivery models (onsite/offshore/hybrid) based on project needs and site maturity. Support pricing strategies and effort estimation based on risk and compliance expectationsThought Leadership & Market PositioningCreate 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 roadshowsMonitor regulatory trends and translate them into service offeringsCollaborate with Marketing on thought leadership white papers, webinars, conference talks (ISPE/PDA), and client workshops.Account Growth & EnablementBuild 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.Delivery Oversight & Execution SupportProject OversightOversee 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 LeadershipDesign 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 elevate 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 GovernanceWork seamlessly with global teams across timelines and cultural contextsEstablish standardized templates, best practices, and checklists across CQV projectsDrive continuous improvement in delivery methodology, validation approaches, and documentation qualityDirect blended teams (onsite/remote/offshore); set clear objectives, templates/standards, and working agreementsCoach project leads/consultants; resolve technical blockers; ensure consistent application of risk-based practices and right-sizing documentationMonitor scope, schedule, cost, and client satisfaction; drive issue resolution and continuous improvementStakeholder ManagementInterface 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.Internal Enablement & Capability BuildingMentor validation engineers, team leads, and junior SMEsSupport internal training initiatives on CQV trends, tools, and regulatory expectationsContribute to solution accelerators, reusable templates, and playbooksStrengthen collaboration between BD, delivery, and practice leadership teamsRequirementsQualificationsBachelor's or master's in engineering, Life Sciences, Pharmacy, or related field10-15 years in CQV/Validation within pharma/biotech (at least 5 years in client-facing leadership or program oversight). Demonstrated pre?sales experience is requiredTechnical 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 commissioningCSV/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/monitoringLaboratory & 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 leadershipTools/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/Pre?Sales Win rate; qualified pipeline generated; proposal quality and cycle time; account growth; CSAT during orals/POCsDelivery 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 membersThought Leadership Number/quality of publications, webinars, conference talks; client workshops delivered; internal enablement sessionsTravel & Work ModelAbility to travel (~20-40%, variable) for client workshops, site commissioning/qualification, and executive reviews. Comfortable leading hybrid delivery with remote/offshore teamsJ-18808-Ljbffr