The GMP Operations Supervisor plays a critical role in ensuring operational excellence and compliance within Capricor’s GMP environment. This position is responsible for managing and executing equipment validation, calibration and preventive maintenance schedules, coordinating vendor activities, and supporting facilities operations to uphold the highest standards of quality and regulatory compliance. The ideal candidate is detail-oriented, proactive, and thrives in a fast-paced, dynamic setting where precision and collaboration are key.
RESPONSIBILITIES
Oversee and manage GMP Operations engineers on validation best practices, execution and documentationMaintain and update calibration and preventive maintenance (PM) schedules for GMP-controlled equipment.Execution of equipment validation and re-validation activities in coordination with our Quality Engineering TeamSupport the induction and documentation of controlled assets in alignment with compliance requirements.Coordinate daily, weekly, and monthly facilities tasks to ensure uninterrupted operations.Schedule PM and calibration activities with external vendors and collaborate with internal teams to minimize operational impact.Partner with Quality Assurance (QA) on vendor qualification and compliance verification.Work closely with Quality Engineering to ensure timely completion and closure of equipment-related work orders.Communicate with vendors for troubleshooting and repair needs, ensuring swift resolution.Assist in managing quality records, including deviations, CAPAs, and change controls related to GMP operations and facilities.Contribute to the revision and upkeep of equipment documentation and SOPs.Ensure all activities adhere to GMP regulations, internal policies, and industry best practices.
REQUIREMENTS
Bachelor’s degree in Engineering, Life Sciences, or a related field preferred; equivalent experience considered.Familiarity with GMP regulations and standards governing equipment and facilities operations.Basic understanding of calibration and maintenance processes for controlled equipment.Strong organizational and time-management skills with the ability to prioritize multiple tasks.Excellent communication and coordination skills for effective vendor and team interactions.Ability to work independently while maintaining a collaborative approach.Detail-oriented with strong problem-solving capabilities.Experience with quality management systems or documentation processes is a plus.Comfortable operating in a fast-paced, highly regulated environment.