Zifo

Title: Veeva QMS Consultant Remote Compliance Services Bloomington, Indiana, United States Job Description: **This role is open to remote candidates who have availability to travel to the client in Bloomington, IN on a regular basis** Zifo is seeking a highly skilled and detail-oriented Veeva QMS consultant to support the implementation, optimization, and ongoing management of Quality Management Systems (QMS) within a regulated scientific environment. This role will focus on leveraging Veeva Vault QMS solutions to ensure compliance, streamline processes, and enhance operational efficiency across quality and regulatory functions. The ideal candidate combines strong scientific domain knowledge with technical expertise in QMS platforms and Veeva Vault applications. Responsibilities: - 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 withVeeva 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.

Role Description Zifo is hiring an experienced Bioinformatician with a Scientific Informatics background. Someone that can build scientific relationships, understand industry challenges and shape our Bioinformatics Solutions, working in collaboration with our global Bioinformatics, Cloud and Data Science teams. This is an exciting opportunity to join our Global Bioinformatics Team to help leading Pharmaceutical and Biotech customers deploy and support cutting edge Bioinformatics Solutions and Technology globally. You will be responsible for deploying solutions that play a critical role in the early-stage optimization and development of assays by supporting analysis and interpretation of data for large biotech/pharma and other ‘Omics focused companies. Responsibilities: - Understand current and emergent Bioinformatics problems, needs, requirements analysis, and design. - Engage the market and the genetics/-omics’ community to develop, commercialize, and expand our bioinformatics and multi-omics services taking input from customers, literature and conferences. - Deliver timely, scalable NGS and ‘omics solutions (e.g. genomics, transcriptomics, metagenomics, epigenomics, microbiome, metabolomics, single-cell and spatial omics and proteomics). - Apply molecular techniques, bioinformatics pipelines, relational data systems, and statistical analysis to generate biological insights using internal and external data sets, published literature, and other resources to accelerate biomarker discoveries. - Deliver robust, in-depth, and state-of-the-art analysis pipelines. - Integrate AI-driven approaches into bioinformatics workflows, including the use and fine-tuning of biological foundation models (e.g. scGPT and similar models) to enhance interpretation of multi-omics data. - Manage multiple projects simultaneously and complete analyses in a timely and reliable manner. - Research, assess, recommend, and integrate Bioinformatics Technology platforms. - Help customers estimate, plan, and prioritize Bioinformatics Technology implementation. - Be hands-on involved in critical bioinformatics program delivery. Qualifications - PhD or PostDoc in Computational Biology, Bioinformatics, Statistical Genetics. - Background in Oncology, Immunology, Neuroscience is a plus. - Knowledge and understanding of public databases & tools (GEO, TCGA, OpenTargets et al), applications in drug discovery, analysis and integration of multi-omics & biobank data. - Ability to correlate results, generate hypothesis and scientific insights for applications in biomarker identification, indication selection and patient stratification. - Experience with biological foundation models, including fine-tuning and application of models such as scGPT, and other transformer-based or generative models for single-cell and multi-omics data, is highly desirable. Benefits - Competitive compensation package. - Accrued vacation. - Medical, dental, and vision insurance. - 401k with company matching. - Life insurance. - Flexible spending accounts. Company Description 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. 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.

• Understand current and emergent Bioinformatics problems, needs, requirements analysis, and design. • Engage the market and the genetics/-omics’ community to develop, commercialize, and expand our bioinformatics and multi-omics services taking input from customers, literature and conferences. • Deliver timely, scalable NGS and ‘omics solutions (e.g. genomics, transcriptomics, metagenomics, epigenomics, microbiome, metabolomics, single-cell and spatial omics and proteomics). • Apply molecular techniques, bioinformatics pipelines, relational data systems, and statistical analysis to generate biological insights using internal and external data sets, published literature, and other resources to accelerate biomarker discoveries. • Deliver robust, in-depth, and state-of-the-art analysis pipelines. • Integrate AI-driven approaches into bioinformatics workflows, including the use and fine-tuning of biological foundation models (e.g. scGPT and similar models) to enhance interpretation of multi-omics data. • Manage multiple projects simultaneously and complete analyses in a timely and reliable manner. • Research, assess, recommend, and integrate Bioinformatics Technology platforms. • Help customers estimate, plan, and prioritize Bioinformatics Technology implementation. • Be hands-on involved in critical bioinformatics program delivery.

Role Description Zifo is hiring an experienced Bioinformatician with a Scientific Informatics background. Someone that can build scientific relationships, understand industry challenges and shape our Bioinformatics Solutions, working in collaboration with our global Bioinformatics, Cloud and Data Science teams. Our customers are accelerating their Scientific Informatics and Digital Transformation to accelerate the discovery and manufacturing of new Therapeutics, Drugs and Vaccines to save lives Faster! Consequently, we are rapidly growing and looking to expand our Bioinformatics team in North America. This is an exciting opportunity to join our Global Bioinformatics Team to help leading Pharmaceutical and Biotech customers deploy and support cutting edge Bioinformatics Solutions and Technology globally. You will be responsible for deploying solutions that play a critical role in the early-stage optimization and development of assays by supporting analysis and interpretation of data for large biotech/pharma and other ‘Omics focused companies. By leading solution deployments for your customers, you engage, consult, design and implement global Bioinformatics Solutions that establish industry-leading Bioinformatics, Omics and Technology practices that are robust and scalable. - Understand current and emergent Bioinformatics problems, needs, requirements analysis, and design. - Engage the market and the genetics/-omics’ community to develop, commercialize, and expand our bioinformatics and multi-omics services taking input from customers, literature and conferences. - Deliver timely, scalable NGS and ‘omics solutions (e.g. genomics, transcriptomics, metagenomics, epigenomics, microbiome, metabolomics, single-cell and spatial omics and proteomics). - Apply molecular techniques, bioinformatics pipelines, relational data systems, and statistical analysis to generate biological insights using internal and external data sets, published literature, and other resources to accelerate biomarker discoveries. - Deliver robust, in-depth, and state-of-the-art analysis pipelines. - Integrate AI-driven approaches into bioinformatics workflows, including the use and fine-tuning of biological foundation models (e.g. scGPT and similar models) to enhance interpretation of multi-omics data. - Manage multiple projects simultaneously and complete analyses in a timely and reliable manner. - Research, assess, recommend, and integrate Bioinformatics Technology platforms. - Help customers estimate, plan, and prioritize Bioinformatics Technology implementation. - Be hands-on involved in critical bioinformatics program delivery. Qualifications - PhD or PostDoc in Computational Biology, Bioinformatics, Statistical Genetics. - Background in Oncology, Immunology, Neuroscience is a plus. - Knowledge and understanding of public databases & tools (GEO, TCGA, OpenTargets et al), applications in drug discovery, analysis and integration of multi-omics & biobank data. - Ability to correlate results, generate hypothesis and scientific insights for applications in biomarker identification, indication selection and patient stratification. - Experience with biological foundation models, including fine-tuning and application of models such as scGPT, and other transformer-based or generative models for single-cell and multi-omics data, is highly desirable. Benefits - Competitive compensation package. - Accrued vacation. - Medical, dental, and vision insurance. - 401k with company matching. - Life insurance. - Flexible spending accounts. Company Description 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. 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.

• Engage as a leader to define and own project success, leveraging core consulting behaviours such as active listening, empathetic collaboration, strong sense of ownership and effective communication across multiple audiences • Own accountability for business analysis deliverables including user requirements specifications (URS), functional requirements specifications, data & process maps, workflows, gap analyses, implementation roadmaps, evaluation methodologies, and questionnaires. • Conduct vendor evaluations and define implementation strategies to enable effective decision-making by pharma/biotech/agritech clients. • Assess system landscapes and contribute to IT, informatics and data landscape roadmaps. • Manage one or more large projects/programs, including estimation, scheduling, risk management, and milestone tracking. • Facilitate project meetings, communicate status updates, and escalate risks when necessary. • Mentor associates across Zifo, guiding their project engagements and professional development. • Track and monitor key project metrics to ensure the success of client engagements as well as adherence to operational components of project delivery. • Serve as primary point of contact for clients and internal stakeholders, managing expectations on process, quality, schedule, and delivery - all with an overall view of what qualifies as successful engagement • Build rapport with client managers and support and/or drive strategic customer meetings. • Identify opportunities for additional value creation within client organizations and internal process improvements. • Plan and track billable effort, manage utilization and productivity of themselves and teams, and support budget forecasting. • Manage escalations, identify & track risks to project execution, initiate corrective and preventive actions (CAPA) and drive continuous improvement initiatives. • Support internal training programs, and mentor team members in emerging areas. • Assist in proposals related to emerging opportunities with clients and supporting RFP responses. • Contribute to case studies, presentations, and white papers. • Attend industry conferences for learning, networking, and representing Zifo.

About Zifo:  Zifo is a global scientific and technical consulting partner specializing in strategy, informatics, and innovation for clients in life sciences organizations, such as pharmaceutical R&D, biotechnology, and agritech. We help organizations accelerate discovery, optimize development pipelines, and leverage data to achieve measurable impact.    Position Overview:  The Associate Scientific Strategy Consultant sits within the North American consulting group wherein key accountabilities include driving project elucidation, stakeholder management and defining & driving project success in partnership with internal and external stakeholders. The successful candidate will lead medium-to-high complexity consulting engagements for multiple customers. This role blends scientific expertise, industry knowledge, and informatics/data skills with leadership and collaboration to deliver high-quality solutions. You will work closely with senior consultants, client stakeholders, and cross-functional teams to ensure project success, drive operational excellence, and contribute to business development.  Key Responsibilities:  Consulting & Scientific Strategy  - Engage as a leader to define and own project success, leveraging core consulting behaviours such as active listening, empathetic collaboration, strong sense of ownership and effective communication across multiple audiences  - Own accountability for business analysis deliverables including user requirements specifications (URS), functional requirements specifications, data & process maps, workflows, gap analyses, implementation roadmaps, evaluation methodologies, and questionnaires.  - Conduct vendor evaluations and define implementation strategies to enable effective decision-making by pharma/biotech/agritech clients.  - Assess system landscapes and contribute to IT, informatics and data landscape roadmaps.  Project Execution & Leadership  - Manage one or more large projects/programs, including estimation, scheduling, risk management, and milestone tracking.  - Facilitate project meetings, communicate status updates, and escalate risks when necessary.  - Mentor associates across Zifo, guiding their project engagements and professional development.  - Track and monitor key project metrics to ensure the success of client engagements as well as adherence to operational components of project delivery.  Customer Engagement & Collaboration  - Serve as primary point of contact for clients and internal stakeholders, managing expectations on process, quality, schedule, and delivery - all with an overall view of what qualifies as successful engagement  - Build rapport with client managers and support and/or drive strategic customer meetings.  - Identify opportunities for additional value creation within client organizations and internal process improvements.  Operational Excellence & Continuous Improvement  - Plan and track billable effort, manage utilization and productivity of themselves and teams, and support budget forecasting.  - Manage escalations, identify & track risks to project execution, initiate corrective and preventive actions (CAPA) and drive continuous improvement initiatives.  - Support internal training programs, and mentor team members in emerging areas.  Business Development & Thought Leadership  - Assist in proposals related to emerging opportunities with clients and supporting RFP responses.  - Contribute to case studies, presentations, and white papers.  - Attend industry conferences for learning, networking, and representing Zifo.  Learning, Mentorship & Continuous Improvement  - Demonstrate continuous learning in scientific domains, informatics systems and data strategies, change management and strategic consulting methodologies.  - Identify needs and drive efforts for internal development and knowledge-sharing initiatives.  - Mentor other analysts across business units within Zifo, fostering collaboration career development.

• 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.

**This role is open to remote candidates who have availability to travel to the client in Bloomington, IN on a regular basis** Zifo is seeking a highly skilled and detail-oriented Veeva QMS consultant to support the implementation, optimization, and ongoing management of Quality Management Systems (QMS) within a regulated scientific environment. This role will focus on leveraging Veeva Vault QMS solutions to ensure compliance, streamline processes, and enhance operational efficiency across quality and regulatory functions. The ideal candidate combines strong scientific domain knowledge with technical expertise in QMS platforms and Veeva Vault applications. Responsibilities: - 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.

• Responsible for validation strategy and planning, executing and qualification of computer systems and/or infrastructure components in accordance with applicable policies procedures and regulatory requirements

Responsible for validation strategy and planning, executing and qualification of computer systems and/or infrastructure components in accordance with applicable policies procedures and regulatory requirements