CQV Practice Lead – Business Development, Delivery

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the main CQV Subject Matter Expert (SME) during pre-sales engagements with pharmaceutical and biotech clients.

• Identify opportunities for qualification and validation across laboratory, manufacturing, quality control, and quality control IT environments.

• Recognize qualification opportunities for facilities, utilities, and equipment, including cleanrooms, HVAC systems, compressed gases, water systems, autoclaves, incubators, and environmental monitoring systems.

• Create solutions and effort models for Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and performance verification.

• Facilitate requirement gathering sessions, customer workshops, and in-depth technical meetings.

• Cultivate trusted advisor relationships with client stakeholders.

• Develop CQV solution strategies using ASTM E2500, ISPE Baseline Guides, GAMP 5 (2nd Edition), and ICH Q9/Q10 guidelines.

• Design onsite, offshore, and hybrid delivery models, including timelines, governance, and staffing plans.

• Create comprehensive CQV solutions, including estimates, assumptions, risk mitigation strategies, and inputs for Statements of Work (SOW) and pricing.

• Lead responses to Requests for Proposals (RFPs) and Requests for Information (RFIs), preparing technical content, proposals, executive summaries, capability presentations, oral presentations, demonstrations, and case studies.

• Develop thought leadership materials and represent the company at conferences, industry forums, and client roadshows.

• Stay informed on regulatory trends and translate these into service offerings.

• Identify opportunities for cross-selling and upselling in related validation and data integrity services.

• Manage CQV engagements that involve analytical instruments, manufacturing equipment, laboratory equipment, CSV, and qualification of facilities and utilities.

• Establish governance processes, manage RAID (Risks, Assumptions, Issues, Dependencies), change control, adherence to Quality Management Systems (QMS), and compliance with project stage-gate requirements.

• Assist project managers with scope alignment, risk management, and ensuring timely delivery.

• Design risk-based qualification strategies and approaches from Computerized System Validation (CSV) to Computer System Assurance (CSA).

• Provide guidance to validation consultants on qualification strategies, deviations, test design, and documentation quality.

• Diagnose technical issues and proactively escalate risks.

• Review and approve validation plans, test protocols, summary reports, traceability matrices, and risk assessments.

• Ensure compliance with Good Practice (GxP), data integrity guidelines, and expectations set by the FDA, EMA, WHO, and ICH.

• Maintain audit readiness and defend validation methodologies during internal and external audits.

• Develop standardized templates, best practices, and checklists.

• Direct blended teams comprising onsite, remote, and offshore personnel; establish objectives, standards, and working agreements.

• Mentor project leads and consultants, address technical obstacles, and promote continuous improvement.

• Oversee scope, schedule, budget, and customer satisfaction.

• Interact with stakeholders from Quality Assurance (QA), CQV, Manufacturing Science & Technology (MS&T), Manufacturing, IT/CSV, Clinical, Quality, and Supply Chain.

• Communicate project status and risks to executive sponsors while aligning priorities and success metrics.

• Mentor validation engineers, team leaders, and junior SMEs.

• Assist with internal training initiatives and contribute to solution accelerators, reusable templates, and playbooks.

• Enhance collaboration among business development, delivery, and practice leadership teams.

⛳️ Requirements

• Bachelor’s or master’s degree in engineering, Life Sciences, Pharmacy, or a related discipline.

• 10 to 15 years of experience in CQV/Validation within the pharmaceutical or biotech industries.

• Minimum of 5 years in client-facing leadership roles or program oversight.

• Proven pre-sales experience is essential.

• Familiarity with ASTM E2500, ISPE Baseline Guides, ICH Q9/Q10, risk-based qualification, FAT/SAT, DQ/IQ/OQ/PQ/PPQ, cleaning validation fundamentals, utilities (WFI/PW/HVAC), and commissioning of facilities/equipment.

• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 (2nd Edition), Data Integrity (ALCOA+), risk-based testing, supplier evaluation, periodic review, and continuous verification/monitoring.

• Strong skills in solution development and scoping, proposal writing, stakeholder engagement, delivery governance, risk management, and both written and verbal communication, coaching, and team leadership.

• Proficiency with validation lifecycle tools, test management, requirements traceability, and documentation software such as Veeva Vault QMS/DMS, JIRA, Confluence, and MS Project.

• Willingness to travel approximately 20 to 40% for client workshops, site commissioning/qualification, and executive reviews.

• Ability to lead hybrid delivery involving remote and offshore teams.

🏝️ Benefits

• Accrued vacation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k with company matching contributions.

• Life insurance.

• Flexible spending accounts.

• Equal opportunity employer.

• Diverse and inclusive workplace culture.