Veeva QMS Consultant

🕒 March 30

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

💼 Consultant

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Zifo

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Zifo is a global specialist scientific and process informatics service provider working in research, development, manufacturing, and clinical domains. They offer a wide range of services including scientific IT services, cloud migration, bioinformatics consulting, data science, and digital transformation. Zifo serves industries such as pharmaceuticals, biotechnology, contract research organizations, and more. They are committed to advancing scientific discovery through innovative solutions and expert consulting, catering to the needs of science-driven organizations.

📋 Description

• Lead the implementation, configuration, and support of QMS applications, with a focus on Veeva Vault QMS. • Collaborate with cross-functional stakeholders (Quality, Regulatory, R&D, IT) to gather requirements and translate them into system solutions. • Ensure compliance with industry regulations (e.g., GxP, FDA, ISO standards) through proper system design and usage. • Provide subject matter expertise on QMS processes including CAPA, Change Control, Deviations, Audits, and Document Management. • Configure and maintain Veeva Vault modules to support business processes and regulatory requirements. • Conduct system validation activities, including documentation, testing, and change control. • Support data migration, system upgrades, and integrations with other enterprise systems. • Deliver end-user training and provide ongoing support to ensure effective system adoption. • Identify opportunities for process improvement and system optimization. • Participate in audits and inspections, providing system-related support and documentation.

🎯 Requirements

• QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent). • Veeva Certification, specifically related to Veeva Vault (QMS preferred). • Proven experience working with Quality Management Systems (QMS) in regulated environments. • Hands-on experience with Veeva Vault QMS, including configuration and administration. • Strong understanding of GxP compliance requirements and validation processes (CSV/CSA). • Experience with quality processes such as CAPA, Change Control, Deviations, and Audits. • Excellent analytical, problem-solving, and communication skills. • __**Qualifications**__ • Bachelor or Master’s degree in Life sciences or Computer Sciences • 5+ years’ experience with Computer Systems Validation is required for this role • Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirements • QMS Certification (e.g., ASQ, ISO-related certifications, or equivalent). • Veeva Certification, specifically related to Veeva Vault (QMS preferred). • Proven experience working with Quality Management Systems (QMS) in regulated environments. • Hands-on experience with Veeva Vault QMS, including configuration and administration. • Strong understanding of GxP compliance requirements and validation processes (CSV/CSA). • Experience with quality processes such as CAPA, Change Control, Deviations, and Audits. • Excellent analytical, problem-solving, and communication skills.

🏖️ 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.