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-SalesOpportunity 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.
RequirementsQualifications- 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 pre-sales 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/Pre-Sales: 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.
BenefitsWe offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
