Quality Systems Specialist

About Batavia Biomanufacturing

Batavia Biomanufacturing significantly contributes to easing human suffering from infectious diseases, cancer, and rare diseases by leveraging our innovative technologies and in-depth know-how. We do this for viral vaccines and cell and gene therapies at all stages of the development trajectory, from the transition into early clinical studies to navigating late-stage clinical development and entering commercial manufacturing at higher speed, reduced costs, and with increased success. The company operates state-of-the-art development and manufacturing facilities in Europe and the US and, as part of the CJ CheilJedang global family, is building a strong position in global health with its strategic partners worldwide.

About Batavia Biosciences

The short version is that Batavia helps to optimize the route from drug discovery to clinic. The reality is that we do much more than that: by leveraging the combination of our expert workforce, our broad, international academic and public network and our extensive range of high-end services, we design the optimal route for our customers to reach the one person that we all are 100% committed to: the patient.

To help us take biopharmaceutical development to the next level, we look forward to welcome you as our new Quality Systems Administrator.

Position Summary:

We are looking for a meticulous and proactive Quality Systems Administrator to join our QA Systems & Compliance team at our Leiden-based pharmaceutical CDMO facility for clinical trials and commercial manufacturing. In this role, you will be responsible for the day-to-day administration and optimization of our Veeva Vault Quality Suite, supporting GMP compliance and operational excellence across quality processes.

You will play a key role in ensuring that our electronic quality systems are maintained in a validated state, support regulatory readiness, and enable efficient document and training management. This position offers the opportunity to work in a dynamic, fast-paced environment with exposure to global clients and regulatory bodies.

Key Responsibilities:

Veeva Vault Quality System Administration:

- Administer and maintain Veeva Vault modules including QualityDocs, QMS, and Training

- Manage user access, roles, and permissions in accordance with data integrity and security policies

- Monitor and support electronic workflows for deviations, CAPAs, change controls, complaints, suppliers, audits, etc.

- Act as the first point of contact for system-related issues and coordinate with IT and Veeva system owner as needed.

Document Control & Quality Records:

- Oversee the system for lifecycle of controlled documents (SOPs, WI, batch records, etc.)

- Ensure the system provides a timely routing, review, approval in compliance with internal procedures and regulatory requirements

- Maintain audit-ready documentation of the system.

Training Management:

- Assign and track training activities in Veeva Training module

- Support onboarding and role-based training compliance for new and existing employees.

- Generate training metrics and compliance reports for internal and external stakeholders

Audit & Inspection Readiness:

- Prepare documentation and system access for regulatory inspections and client audits

- Serve as a system SME during audits, demonstrating Veeva workflows and document traceability

- Support post-audit activities including document retrieval and CAPA tracking

Support & Process Improvement:

- Identify and implement improvements to system workflows and user experience

- Participate in cross-functional projects related to system upgrades, validation, and process harmonization

- Provide training and guidance to end-users on Veeva functionalities and best practices

Qualifications:

Required:

- Minimum 2-3 years of experience in a GMP-regulated pharmaceutical or biotech environment, preferably within a CDMO

- Hands-on experience with Veeva Vault Quality Suite

- Strong understanding of GxP, ICH Q10, and data integrity requirements

- Excellent organizational, communication, and problem-solving skills

- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Preferred:

- Experience supporting regulatory inspections (e.g., FDA, EMA, MHRA)

- Familiarity with electronic batch records (EBR) and manufacturing documentation

- Knowledge of ISO 9001 or other quality management standards

- Bachelor's degree in Life Sciences, Quality Management, or related field

Additional Requirements:

- Logical and creative way of thinking

- Systematic approach to challenges

- Affinity with computer systems, pharmaceutical industry and Quality Assurance

- Motivated to build and maintain structure within systems

- Work within a small team and gather information and feedback from the organization

- Translate feedback from the organization into input for continuous improvement initiatives

What We Offer:

- A collaborative and quality-driven work environment in a growing CDMO

- Opportunities for professional development and cross-functional exposure

- Competitive salary and benefits package

- A place to develop your Veeva knowledge and admin skills

- A chance to contribute to the delivery of high-quality pharmaceutical products to global markets