Quality Systems Specialist

Job Title:

Quality Systems Specialist

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 escalating 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…