Veeva Business Systems Lead

Minaris•Allendale, NJ

2d•Remote

About The Position

The Veeva Business Systems Lead is responsible for leading the design and delivery of the technical business solutions for the Veeva Quality Suite (LMS, DMS, QMS) and its integration with related IT systems (e.g., SAP S/4HANA), as well as the ongoing improvement and efficiency programs (e.g., adding new features/functionality to meet emerging business requirements). This role will be responsible for maintaining and overseeing global Veeva business process standards and capacities based on global client requirements. The Veeva Business Systems Lead provides technical direction to the Veeva Vault System roadmap and provides quality-focused leadership and technical oversight for Veeva-related global Quality business process teams. This role will drive business process teams to develop well-designed and high-functioning Veeva business processes and systems which demonstrate Minaris as a CDMO of choice for the industry.

Requirements

Active Veeva Vault System Administrator Certification (required).
Thorough understanding of data structures within a Veeva Vault QMS implementation (e.g., Audits, CAPA, Change Control, Deviations).
Capable of leading business process-mapping exercises with cross-functional teams and developing SOPs, Wis, and technical training to support process implementation, administration, and improvement.
Demonstrated experience with Veeva Vault data governance, reporting, and dashboard creation.
Proven experience supporting global users across multiple functions and regions.
Proven experience preparing for and supporting regulatory inspections.
Excellent verbal and written communication skills, with the ability to translate technical concepts for non-technical stakeholders.
Strong understanding of US and international GMPs, industry-standard quality processes, and data integrity expectations
Strong problem-solving skills with attention to detail and compliance.
Comfortable working independently while managing multiple priorities in a global environment.
Bachelor's degree (i.e. Life Sciences, IT, or Learning and Development preferred).
7+ years of cGMP environment or similar experience.
5+ years of hands-on experience configuring, administering and supporting Veeva Vault Quality Suite in a regulated GxP environment
3+ years experience mapping/aligning/synchronizing business processes with Veeva processes mapped in Lucid charts and string diagrams
3+ years of leadership experience or equivalent combination of experience.
Deep Understanding of Veeva Vault Platform architecture
Knowledge of adult learning theories and proficiency with training development; content generation, and other learning activities.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Responsibilities

Serve as the global business administrator and Subject Matter Expert (SME) for the Veeva Vault Quality suite (e.g., Vault Platform, Vault QMS, Veeva QualityDocs, and Vault Training).
Manage the Veeva Vault system roadmap in alignment with organizational growth, business priorities, and regulatory expectations.
Own system configuration, user management, security roles, workflows, lifecycles, and metadata in accordance with business and GxP requirements.
Partner with cross-functional stakeholders to gather requirements and implement system enhancements and process improvements.
Lead and support system upgrades, releases, and enhancements, including impact assessments, regression testing, and user communications.
Serve as the primary escalation point for complex system issues, coordinating resolution with Veeva and internal stakeholders.
Act as a key liaison with Veeva MSP, IT System Administrator, Vault Owner and external vendors for system support, enhancements, and issue resolution.
Ensure the Vault Quality system remains inspection-ready and compliant with global GxP regulations (e.g., FDA, EMA, and ICH).
Partner with stakeholders to define, produce, and interpret key system metrics, reports, and dashboards to enable data-driven decision making.
Ensure effective data governance, including data integrity, consistency, and appropriate use of reporting and dashboards.
Support system validation activities in compliance with GxP regulations, including documentation, testing, and ongoing compliance.
Develop and maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and training materials related to system use, administration, and governance.
Act as a strategic advisor to Quality leadership on system capabilities, limitations, and best practices.
Evaluate existing quality processes and proactively recommend process simplification, standardization, and optimization using Vault capabilities.
Mentor and provide guidance to system administrators and key users as needed.
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
Identifies, recruits, and retains top-notch talent.
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
Develop employees to meet both their career and organizational goals.
Builds strong cross-functional relationships and delivers customer-centric business solutions.
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Comfortable working in ambiguous situations and adaptable to change.
Must model the highest degree of moral and ethical behavior and maintain confidential information.
High degree of autonomy and strong decision-making skills.