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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Qms Specialist- Change Control Management - **Company:** Actalent - **Location:** Foster City, CA, United States (Remote available) - **Experience:** Expert - **Salary:** $93,600 - $135,200 - **Contract:** Temporary contract - **Skills:** Databases, Document Management Systems, Document Enterprise Platform, Computerised Systems, GXP - **Published:** November 13, 2026 - **Apply:** https://www.careercircle.com/jobs/all/all/usa/ca/foster-city/8834d061-ced5-4f8b-b4ea-2338d3115ad4 ## About the Role Visionary Leadership Management Innovation Communication Presentations Change Control Pharmaceuticals Detail Oriented Small Molecules Large Molecules Document Control Quality Assurance Biopharmaceuticals Quality Management Compliance Auditing Organizational Skills Quality Management Systems Engineering Design Process Standard Operating Procedure Good Manufacturing Practices Continuous Improvement Process Current Good Manufacturing Practices (cGMPS) At least 6 years, * Minimum of six years of change control experience 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 background with hands-on experience in document control and change control processes. * Demonstrated ability to independently manage, document, and close complex change controls across local and global operations. * Good communication and presentation skills, including the ability to lead trainings for groups of 30 or more people. * Technical science degree (BS or BA) from a scientific or technical background. * Proven experience working within cGMP and GxP quality systems. * Ability to facilitate cross-functional meetings and drive consensus on change-related decisions. * Strong attention to detail and accuracy in documentation and record-keeping. * Ability to analyze and generate quality system metrics and trends, and to support management review activities. Additional Skills & Qualifications * Experience with biologics manufacturing is highly preferred. * Experience with both small molecule and large molecule products is beneficial. * Ability to mentor and provide technical guidance to junior staff. * Comfort working with tracking tools and databases for change control and quality metrics. * Experience participating in compliance audits and supporting audit readiness. * Strong organizational skills and the ability to manage multiple change records and tasks simultaneously., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. ## Description The Quality Systems Specialist manages and improves change control and quality systems within a GMP/GxP manufacturing environment. This role oversees change controls for products, processes, equipment, facilities, and computerized systems, ensuring compliance with quality management system expectations and current Good Manufacturing Practices. The specialist facilitates cross-functional alignment, supports quality metrics and management review processes, and helps maintain high standards for documentation and controlled procedures. Responsibilities * Manage change controls related to manufacturing products, processes, equipment, facilities, and computerized systems, contributing to key strategic, tactical, and operational quality goals. * Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls for both local and global activities in GxP operations. * Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with quality management system expectations. * Navigate complex change review discussions, guide teams to a common decision on approach and follow-up actions, and document all evaluations and decisions accurately. * Support the management and monitoring of change records to ensure adherence to organizational and departmental metric targets, maintaining associated tracking tools and databases. * Develop and generate quality system metrics and trending to support the management review process, and escalate issues when required. * Support the maintenance and continuous improvement of quality systems processes 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 and subject matter expertise on 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 such as standard operating procedures, specifications, and methods as needed. * Provide guidance and technical knowledge to more junior staff and monitor the performance of their daily tasks. * Lead trainings and presentations for groups of approximately 30 or more participants on quality systems and change control processes., The role operates in a regulated GMP/GxP manufacturing environment focused on biologics and other pharmaceutical products. The Quality Systems Specialist collaborates closely with cross-functional teams, stakeholders, and leadership, often participating in structured meetings and formal training sessions for larger groups. Work involves extensive use of computerized systems, quality management tools, and documentation platforms to manage change records, metrics, and controlled documents. The environment emphasizes adherence to cGMP standards, robust documentation practices, and continuous improvement of quality systems processes.