Quality Systems Specialist

Quality Systems Specialist

The Quality Systems Specialist manages and oversees change controls for products, processes, equipment, facilities, and computerized systems within a regulated manufacturing environment. This role ensures that changes align with quality management system expectations, support GxP operations, and maintain compliance with current Good Manufacturing Practices (cGMPs). The specialist works cross-functionally to drive strategic, tactical, and operational quality goals, while maintaining robust documentation and continuous improvement of quality systems.

• Manage change controls related to manufacturing product, process, equipment, facility, and computerized systems, ensuring alignment with strategic, tactical, and operational quality goals.
• Independently review, initiate, execute, and thoroughly document critical, major, and minor change controls for both local and global GxP operations.
• Facilitate cross-functional meetings with stakeholders and leadership to align on proposed changes and ensure compliance with quality management system (QMS) expectations.
• Lead and navigate complex change review discussions, guide teams to a common decision on approach and follow-up actions, and document decisions and evaluations clearly and accurately.
• Support the management and monitoring of change records to ensure adherence to organizational and departmental metric targets.
• Maintain and update tracking tools and databases associated with change records and quality system activities.
• Support the management review process by developing and generating quality system metrics and trending reports, and escalate issues when required.
• Contribute to the maintenance and continuous improvement of quality systems processes, identifying and implementing enhancements as needed.
• Work directly with operating entities and internal partners to ensure timely follow-up and completion of change-related tasks.
• Participate in compliance audits as required, providing documentation, explanations, and support related to change control and quality systems.
• Maintain programs and processes that ensure high-quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Write and implement changes to controlled documents, including standard operating procedures (SOPs), specifications, methods, and related quality documentation.
• Provide guidance and technical knowledge to more junior staff and monitor the performance of their daily tasks to ensure adherence to quality standards.

• Minimum of six years of experience with change control in a GxP environment.
• 6+ years of relevant experience in a GMP environment for biologics manufacturing with a BS or BA degree.
• Strong quality assurance experience within regulated manufacturing environments.
• Hands-on experience with change control processes, including initiation, review, execution, and documentation.
• Proficiency in document control and management of controlled documents such as SOPs, specifications, and methods.
• Demonstrated ability to manage and monitor quality system metrics and trends.
• Experience participating in or supporting compliance audits in a GxP or GMP setting.
• Technical background supported by a degree in a scientific or related technical discipline.
• Ability to facilitate cross-functional meetings and drive alignment on change-related decisions.
• Strong written and verbal communication skills for clear documentation and stakeholder interaction.

• Experience with small molecule and large molecule products, with a strong preference for biologics.
• Background in biologics manufacturing, including familiarity with associated quality and regulatory expectations.
• Experience supporting or contributing to management review processes through preparation of metrics and reports.
• Ability to analyze and interpret quality system data for trending and escalation purposes.
• Experience providing guidance and informal leadership to junior staff within a quality or GxP environment.
• Strong organizational skills and attention to detail in managing multiple change records and quality system activities.
• Comfort working with tracking tools, databases, and electronic quality management systems.

The role operates within a cGMP-regulated manufacturing and quality environment focused on biologics and other pharmaceutical products. The Quality Systems Specialist works closely with cross-functional teams, including operations, quality, and leadership, and frequently participates in structured meetings and formal change review boards. The position involves extensive use of computerized systems, electronic tracking tools, and documentation platforms to manage change controls, metrics, and controlled documents.

Work is performed in a professional office and laboratory or production-adjacent setting where adherence to cGMP, GxP, and internal quality management system procedures is essential. The environment emphasizes collaboration,…