Senior Quality Systems Specialist

Senior Quality Systems Specialist

The Senior Quality Systems Specialist provides advanced support across the Quality Management System (QMS), with a primary focus on Document Control and Training. This role ensures that quality processes are executed accurately, efficiently, and in accordance with applicable regulatory requirements and internal GxP standards. The position works collaboratively with cross-functional teams to maintain controlled documentation, training compliance, supplier oversight, and overall QMS effectiveness.

Key Responsibilities

Document Control Support

• Support the creation, revision, formatting, routing, approval, and archival of controlled documents, including SOPs, work instructions, forms, policies, specifications, and related quality records.
• Execute document workflows within an electronic document management system (EDMS), ensuring accurate metadata, version control, and appropriate approval routing.
• Assist with periodic document reviews and ensure documentation remains current, accurate, and audit-ready.
• Provide guidance to document authors and reviewers regarding document control procedures, standards, and best practices.
• Monitor document lifecycle metrics and identify or escalate issues as appropriate.

Supplier Qualification Support

• Support supplier qualification and re-qualification activities, including collection, review, and maintenance of required documentation.
• Assist with supplier audit scheduling and tracking of audit deliverables, observations, and corrective and preventive actions (CAPAs).
• Maintain and update the Approved Supplier List (ASL).
• Support ongoing monitoring and documentation of supplier performance.

Quality Management System (QMS) Support

• Support the execution and maintenance of QMS processes, including CAPA, change control, deviations, training, document control, and audit readiness.
• Assist with preparation for internal and external audits by gathering documentation, maintaining records, and responding to auditor requests.
• Maintain QMS records to ensure accuracy, completeness, traceability, and compliance with applicable regulatory expectations.
• Contribute to continuous improvement initiatives across the QMS, including process updates, template enhancements, and system improvements.
• Support cross-functional teams in understanding and consistently applying QMS requirements and procedures.

Required

• Bachelor’s degree in a scientific, technical, or related field, or equivalent combination of education and experience.
• 5–7+ years of experience in Quality Systems within the pharmaceutical, biotechnology, medical device, or other regulated industries.
• Hands-on experience with electronic document management systems and learning management systems (LMS/eLMS).
• Strong understanding of document control processes and electronic documentation systems.
• Working knowledge of FDA regulations and GxP requirements.
• Strong communication, organizational, analytical, and problem-solving skills.