Zifo
Principal CQV Consultant
Cary, North Carolina, United States · Principal
H1B sponsorship available$10k-$15kDetected 134 days ago
JiraConfluenceStakeholder ManagementSalesBusiness DevelopmentFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationMentoringPublic SpeakingGxP
About the role
- We are seeking a
Responsibilities
- 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.
- 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 and deliver client orals, capability briefings, demos, and case studies; tailor content to sponsor, QA, and IT stakeholders.
- 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.
- 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.
Nice to have
- QMS (e.g. Veeva Quality Suite), LIMS, CDS (e.g., OpenLab, Chromeleon, Empower), LES/ELN, MES, DMS etc..
Skills
- 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.
- CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT.
Compensation
- $10k-$15k
Benefits
- 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.
- We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
- We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Company info
- 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. ·
- 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.
- 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.
Equal opportunity
- Zifo is an equal opportunity employer, and we value diversity at our company.
This listing is sourced directly from Zifo's careers page and normalized into a canonical job model.