Hybrid Document Control & Training Lead, Quality Assurance chez Matica Bio

Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose-built GMP facility in College Station, Texas, we provide rapid development and scale-up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.

The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market. Come join our dedicated team and Make it Happen With Matica Bio!

Position Opportunity:

The Document Control and Training Lead is responsible for executing and supporting core document and training lifecycle activities within the Quality Management System (QMS). This role ensures the proper routing, issuance, archival, and system tracking of controlled documents and training records in compliance with cGMP requirements.

The Lead acts as a subject matter expert (SME) in the administration of the electronic Document Management System (eDMS) and Learning Management System (eLMS), partnering with functional area leads to support training and document readiness across the organization, and experience in Veeva Vault is strongly preferred. The role also contributes to system maintenance and improvement efforts, assists in preparing metrics and compliance reports, and provides guidance to authors and stakeholders on process requirements. This role also acts as the primary contact for document control and training operations in the absence of the Quality Management Systems Manager, ensuring continuity of service and support.

How you will make an impact:

Key responsibilities:

• Performing document control activities such as lifecycle tracking, periodic review coordination, revision routing, and controlled document issuance through the eDMS.
• Supporting training operations including role/curriculum assignment, training record updates, and compliance tracking in the eLMS.
• Delivering live training sessions including onboarding, system walk-throughs (e.g., Veeva), and procedural refreshers as needed.
• Supporting facilitation of department-led training reviews and curriculum walkthroughs.
• Identifying and escalating system issues, proposing enhancements, and supporting testing or implementation activities.
• Maintaining and updating trackers, dashboards, and SharePoint repositories for document and training visibility.
• Coordinating client-related document submissions to ensure accuracy and timely delivery.
• Supporting off-site archiving and retention of controlled records in alignment with internal retention schedules.
• Providing informal mentorship and training to peers and stakeholders on documentation and training system best practices.

Responsibilities:

Document Control & Compliance

• Execute daily document control operations including routing, approval, issuance, archival, and periodic review.
• Ensure accurate organization and secure storage of documents in both physical and electronic systems.
• Maintain compliance with cGMP, FDA, and internal documentation requirements.
• Support off-site record retention, archiving, and retrieval processes in accordance with the company's retention policy.
• Assist in preparing documentation and reports required for audits and regulatory inspections.
• New user and advanced user training on Veeva QualityDocs

Training Operations

• Administer and maintain training records and curricula in the electronic Learning Management System (eLMS).
• Assign roles and training tasks in coordination with department leads.
• Deliver live training sessions including onboarding, system walk-throughs, and refreshers.
• Generate and review training compliance reports to ensure timely completion.
• Provide guidance on training best practices and system functionality.
• Facilitate department-led curriculum and training reviews.
• Participate in periodic curriculum reviews and support training effectiveness assessments.

System Support & Process Improvement

• Identify system issues or improvement opportunities related to document control or training systems.
• Draft and revise SOPs, Work Instructions, and forms to reflect current practices.
• Support testing and rollout of system updates or workflow enhancements.
• Maintain document and training SharePoint sites and associated dashboards.

Cross-functional Collaboration & Stakeholder Support

• Act as the first point of contact for questions on documentation and training workflows.
• Provide technical support for document formatting and training assignments.
• Mentor internal users on document control and training processes.
• Coordinate submission and tracking of client-related controlled documents.
• Serve as the primary contact for documentation and training operations during manager absence.

Audit & Regulatory Support

• Assist in preparing documentation for regulatory inspections, internal audits, and client reviews.
• Ensure documentation availability and compliance with company quality policies.

• Perform other duties as assigned.

As a future Matican you bring:

Education

• Bachelor’s degree in a life science or equivalent work experience in quality or regulated industry.

Experience

• Minimum 5+ years of experience in document control, training, or quality systems support within a GMP-regulated environment.

Licenses or Certifications

• Not required
• Certifications in GMP, document control, or quality systems are a plus.

Knowledge

• Working knowledge of FDA, EMA, and ICH regulations
• Understanding of version control, audit readiness, training practices

Systems Proficiency

• Familiarity with eQMS and LMS systems such as Veeva Vault, MasterControl, or ComplianceWire.
• Veeva Vault proficiency strongly preferred

Skills

• Detail-oriented
• Strong written/verbal communication
• Excellent time management
• MS Office and SharePoint proficiency

Qualities & Attitude

• Demonstrates initiative, flexibility, and strong work ethic
• Capable of working independently and problem solver
• Collaborative team player
• Informal mentor and coach.

Competencies we look for:

Commitment to Excellence, Problem Solving/Decision Making/Analytical Thinking, Communication Skills, Teamwork/Cooperation/Supportiveness, Flexibility/Adaptability, Initiative/Taking Ownership, Focus on Safety, Ethical/Trustworthiness, Work Ethic/Reliability, Thoroughness, Customer Service

We Value:

Matica’s Values are at the forefront of everything we do, our culture, and the decisions we make. 

• Start with Safety & Quality 
• Choose the Path of Openness, Honesty, and Integrity
• Nurture Our Differences to Enable Our Collective Success
• Learn Continuously to Ensure Our Value and Relevance
• Commit to Delivering Life Altering Therapies