Veeva QMS Specialist

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

The role:

The Veeva QMS Specialist is a highly skilled and detail-oriented team member responsible for providing technical expertise, managing system configuration, supporting system administration and continuous improvement for the Simtra Veeva Quality Management System (QMS). This role serves as a bridge between Quality, IT, Business Admins, and end users, ensuring smooth operation of Veeva QMS modules including Vault Training, Quality Docs, QMS, and Validation Management.

The responsibilities:

• Serve as primary point of contact for Veeva QMS expertise.
• Configure and maintain Veeva QMS modules (e.g., QualityDocs, Vault Training, QMS, Validation Management) in alignment with business requirements and best practices.
• Configure Vault objects, fields, page layouts, workflows, security, roles, and permissions.
• Work with Veeva support and implementation partners to resolve technical issues and drive system optimization.
• Collaborate with Quality, Regulatory, and IT teams to gather requirements and implement workflows and process improvements.
• Support the rollout of new Veeva QMS features, releases, and enhancements.
• Support integrations between Vault and other enterprise systems (e.g., ERP, HR).
• Support management of user accounts, groups, roles, profiles, licensing, permissions, and security settings.
• Perform regular system maintenance, including updates, patches, and system health monitoring.
• Monitor system performance and data integrity, ensuring compliance with applicable regulations (e.g., 21 CFR Part 11, GxP).
• Develop and maintain system documentation, including standard operating procedures (SOPs), work instructions, and user guides.
• Provide training, documentation, and user guidance for internal stakeholders.
• Participate in audits and inspections, providing system-related documentation and support.
• Continuously evaluate processes and suggest improvements to optimize system performance and usability.

Desired qualifications:

• Bachelor's or Master's degree in Computer Science, Information Technology, Life Sciences, or a related field.
• Advanced experience in Veeva Vault Quality (QMS, Vault Training, and QualityDocs) data and document migration tools. Experience with cloud-based solutions as well as on-premise solutions.
• Strong understanding of life sciences regulations and compliance requirements, including experience with validation processes as well as with GxP-validated systems, processes, and documentation requirements.
• Familiarity with GxP compliance, electronic records/signatures (21 CFR Part 11), and validation principles.
• Proven track record of leading technical teams and managing complex projects, with excellent problem-solving and decision-making skills.
• Strong critical thinking, analytical, problem-solving, and conflict-resolution skills, along with the ability to multitask and prioritize effectively in a fast-paced environment.
• Strong verbal and written communication skills, with the ability to effectively convey technical concepts to non-technical stakeholders and build strong relationships with both internal and external teams.
• Experience with system administration, configuration, and ticket tracking.

Preferred experience:

• Veeva Platform Configuration Specialist, Veeva Associate Platform Administrator Certification, or equivalent experience.
• Experience with Veeva Vault API or integrations.
• Background in quality assurance, regulatory affairs, or IT in a life sciences environment.

In return, you'll be eligible for[1]:

• Day One Benefits
  
  
  
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    
    
    
    • Spouse Life Insurance
    • Child Life Insurance
    
    
    
    
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    
    
    
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
    
    
    
    
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  
  
  
  
• Additional Benefits
  
  
  
  • Voluntary Insurance Benefits
    
    
    
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
    
    
    
    
  • Onsite Campus Amenities
    
    
    
    • Workout Facility
    • Cafeteria
    • Credit Union
    
    
    
    
  
  
  
  

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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