CQV Practice Lead – Business Development, Delivery

Stellenbeschreibung:

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 escalation 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

Requirements

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

Core Competencies

Demonstrates extensive expertise in CQV processes, including risk-based qualification strategies and compliance with regulatory standards such as GxP and FDA guidelines. Proven ability to lead client engagements, develop comprehensive validation solutions, and manage cross-functional teams effectively.