Job Opportunities API

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 adhe