CQV Practice Lead – Business Development, Delivery

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🕒 vor 20 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

💰 Mitarbeiter im Business Development (BDR)

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Zifo

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

💼 Beratung

🏥 Gesundheitswesen

📦 Logistik

Consulting • Healthcare • Logistics

Zifo ist ein global tätiger Spezialist für wissenschaftliche und prozessbezogene Informatikdienstleistungen, der in den Bereichen Forschung, Entwicklung, Produktion und klinische Domänen tätig ist. Sie bieten ein breites Spektrum an Dienstleistungen, darunter wissenschaftliche IT-Services, Cloud-Migration, Bioinformatik-Beratung, Data Science und digitale Transformation. Zifo bedient Branchen wie Pharmazeutika, Biotechnologie und Auftragsforschungsunternehmen und mehr. Sie setzen sich dafür ein, durch innovative Lösungen und fachkundige Beratung wissenschaftliche Entdeckungen voranzutreiben und dabei die Bedürfnisse von wissenschaftlich orientierten Organisationen zu erfüllen.

Beschreibung

• Act as the primary CQV SME during pre-sales discussions with pharma/biotech clients • Identify qualification and validation opportunities across laboratories, manufacturing, QC, and QC IT landscapes • Identify facility, utilities, and equipment qualification opportunities, including cleanrooms, HVAC, compressed gases, water systems, autoclaves, incubators, and environmental monitoring systems • Develop solutions and effort models for FAT/SAT support, commissioning, IQ/OQ/PQ, and performance verification • Lead requirement discovery sessions, customer workshops, and technical deep-dive meetings • Build trusted advisor relationships with client stakeholders • Shape CQV solution approaches using ASTM E2500, ISPE Baseline Guides, GAMP 5 2nd Ed., and ICH Q9/Q10 • Architect onsite, offshore, and hybrid delivery models, timelines, governance, and staffing plans • Develop end-to-end CQV solutions, estimates, assumptions, risk mitigation approaches, and SOW/pricing inputs • Lead RFP/RFI responses and prepare technical content, proposals, executive summaries, capability decks, orals, demos, and case studies • Create thought leadership content and represent the company at conferences, industry forums, and customer roadshows • Monitor regulatory trends and translate them into service offerings • Identify cross-sell and upsell opportunities in adjacent validation and data integrity services • Oversee CQV engagements involving analytical instruments, manufacturing equipment, lab equipment, CSV, facility, and utilities qualification • Establish governance cadences, RAID management, change control, QMS adherence, and project stage-gate compliance • Support project managers with scope alignment, risk management, and on-time delivery • Design risk-based qualification strategies and CSV-to-CSA approaches • Advise validation consultants on qualification strategy, deviations, test design, and documentation quality • Troubleshoot technical issues and proactively escalate risks • Review and approve validation plans, test protocols, summary reports, traceability matrices, and risk assessments • Ensure alignment with GxP, data integrity guidelines, FDA, EMA, WHO, and ICH expectations • Ensure audit readiness and defend validation approaches during internal and external audits • Establish standardized templates, best practices, and checklists • Direct blended onsite, remote, and offshore teams; set objectives, standards, and working agreements • Coach project leads and consultants, resolve technical blockers, and drive continuous improvement • Monitor scope, schedule, cost, and client satisfaction • Interface with QA, CQV, MS&T, Manufacturing, IT/CSV, Clinical, Quality, and Supply stakeholders • Communicate status and risks to executive sponsors and align priorities and success criteria • Mentor validation engineers, team leads, and junior SMEs • Support internal training and contribute to solution accelerators, reusable templates, and playbooks • Strengthen collaboration between business development, delivery, and practice leadership teams

🎯 Anforderungen

• 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 required • Knowledge of 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 • Knowledge of 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 • Proficiency with solutioning and scoping, proposal writing, stakeholder management, delivery governance, risk management, written and verbal communication, coaching, and team leadership • Proficiency with validation lifecycle tools, test management, requirements traceability, and documentation toolsets such as Veeva Vault QMS/DMS, JIRA, Confluence, and MS Project • Ability to travel approximately 20–40% for client workshops, site commissioning/qualification, and executive reviews • Comfortable leading hybrid delivery with remote/offshore teams

🏖️ Vorteile

• Accrued vacation • Medical insurance • Dental insurance • Vision insurance • 401k with company matching • Life insurance • Flexible spending accounts • Equal opportunity workplace • Diverse and inclusive workplace culture