CQV Practice Lead – Business Development, Delivery

Jobtailor; Deutschland; Hybrid; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced CQV/Validation leader to act as the primary SME during pre-sales discussions with pharma/biotech clients. The role involves identifying qualification and validation opportunities across labs, manufacturing, QC, and QC IT landscapes, and shaping CQV solution approaches using industry standards.

You will lead discovery sessions, build trusted advisor relationships, develop end-to-end CQV solutions and estimates, support RFP/RFI responses, and ensure regulatory

Qualifikationen

• Bachelor’s or master's degree 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, and GAMP 5 basics.

Aufgaben

• 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.
• Develop end-to-end CQV solutions, estimates, assumptions, risk mitigation approaches, and SOW/pricing inputs.
• Lead requirement discovery sessions, customer workshops, and technical deep-dive meetings.
• Lead RFP/RFI responses and prepare technical content, proposals, and case studies.
• 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.
• Monitor scope, schedule, cost, and client satisfaction.

Kenntnisse

CQV/Validation Expertise

Pre-Sales Experience

Regulatory Compliance Knowledge

Proposal Writing Proficiency

Client-Facing Leadership

Ausbildung

Bachelor’s or Master’s in Engineering, Life Sciences, Pharmacy, or related field

Tools

Veeva Vault QMS/DMS

JIRA

Confluence

MS Project

Jobbeschreibung

• 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.

Highest-signal resume keywords

• CQV/Validation Expertise
• Pre-Sales Experience
• Regulatory Compliance Knowledge
• Proposal Writing Proficiency
• Client-Facing Leadership

Hard Skills

• CQV Process Development
• Risk-Based Qualification
• FAT/SAT Support
• DQ/IQ/OQ/PQ/PPQ Knowledge
• Validation Lifecycle Tools
• Data Integrity (ALCOA+)
• Facility Commissioning
• Utilities Qualification
• Analytical Instrument Qualification
• Cleaning Validation Basics

Soft Skills

• Stakeholder Management
• Coaching
• Team Leadership
• Communication
• Continuous Improvement

Industry Keywords

• Pharma
• Biotech
• GxP
• FDA
• EMA
• ICH Q9/Q10
• ASTM E2500
• ISPE Baseline Guides
• GAMP 5
• 21 CFR Part 11

Tools & Technologies

• Veeva Vault QMS/DMS
• JIRA
• Confluence
• MS Project