Job Description

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 adherence to the client’s QMS and project stage gates
• Support project managers in ensuring scope alignment, risk management, and on-time delivery.

Technical Leadership

• Design risk-based qualification strategies for equipment, utilities, and facilities (URS, QRA, DQ/IQ/OQ/PQ/PPQ), and CSV to CSA approaches for lab/manufacturing systems (21 CFR Part 11, Annex 11, Data Integrity/ALCOA+).
• Advise and guide onsite/remote validation consultants on qualification strategy, deviations, test design, and documentation quality.
• Troubleshoot technical issues and escalate risks proactively to both internal teams and clients.
• Review and approve critical deliverables such as validation plans, test protocols, summary reports, traceability matrices, and risk assessments.
• Ensure alignment with GxP, data integrity guidelines, FDA, EMA, WHO, and ICH expectations.
• Provide technical QA on key deliverables (URS, QRA, protocols, summary reports, traceability matrices, validation plans/reports).
• Ensure audit readiness and defend validation approach in internal/external audits (e.g., FDA, EMA).

Team Collaboration & Quality Governance

• Work seamlessly with global teams across timelines and cultural contexts.
• Establish standardized templates, best practices, and checklists across CQV projects.
• Drive continuous improvement in delivery methodology, validation approaches, and documentation quality.
• Direct blended teams (onsite/remote/offshore); set clear objectives, templates/standards, and working agreements.
• Coach project leads/consultants; resolve technical blockers; ensure consistent application of risk-based practices and right-sizing documentation.
• Monitor scope, schedule, cost, and client satisfaction; drive issue resolution and continuous improvement.

Stakeholder Management

· Interface with client such as QA, CQV, MS&T, Manufacturing, IT/CSV, and business functions (Clinical, Quality, Supply).

· Communicate status and risks effectively to executive sponsors; align priorities and success criteria.

3. Internal Enablement & Capability Building

• Mentor validation engineers, team leads, and junior SMEs.
• Support internal training initiatives on CQV trends, tools, and regulatory expectations.
• Contribute to solution accelerators, reusable templates, and playbooks.
• Strengthen collaboration between BD, delivery, and practice leadership teams.

Requirements

Qualifications

• 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 is required.
• Technical Depth (examples):
• CQV: 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.
• CSV/CSA: 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 .
• Laboratory & Enterprise Systems (nice-to-have): QMS (e.g. Veeva Quality Suite), LIMS, CDS (e.g., OpenLab, Chromeleon, Empower), LES/ELN, MES, DMS etc..
• Core Skills: Solutioning and scoping; proposal writing; stakeholder management; delivery governance; risk management; excellent written and verbal communication; coaching and team leadership.
• Tools/Methods: Proficiency with validation lifecycle tools, test management, requirements traceability, and standard documentation toolsets (e.g., Veeva Vault QMS/DMS, JIRA, Confluence, MS Project).

Key Performance Indicators (KPIs)

• BD/Pre‑Sales: Win rate; qualified pipeline generated; proposal quality and cycle time; account growth; CSAT during orals/POCs.
• Delivery Oversight: On-time/on-budget delivery; audit/inspection outcomes; defect escape rates; change control efficacy; stakeholder satisfaction (NPS/CSAT).
• Leadership & Impact: Adoption of risk-based practices; reusables/accelerators created; mentor feedback; retention and engagement of team members.
• Thought Leadership: Number/quality of publications, webinars, conference talks; client workshops delivered; internal enablement sessions.

Travel & Work Model

• Ability to travel (~20–40%, variable) for client workshops, site commissioning/qualification, and executive reviews. Comfortable leading hybrid delivery with remote/offshore teams.

Benefits

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team’s knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies. 

We look for Science – Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a “no doors” policy to promote free access within, we do have a tough door to walk in. We search with a two-point agenda – technical competency and cultural adaptability. 

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling! 

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. 

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