The Stability Coordinator will be responsible for overseeing and coordinating stability testing activities for pharmaceutical development ensuring timely execution of stability pull and testing schedules in collaboration with Contract Manufacturing Organizations CMOs and Contract Testing Organizations CTOs This role involves managing schedules ensuring compliance with procedures and acting as a liaison between internal teams and external partners The ideal candidate will have robust organizational skills experience in pharmaceutical stability programs and a thorough understanding of regulatory requirements Key Responsibilities Coordination of Stability Testing Schedules Develop and manage stability pull and testing schedules in collaboration with CMOs CTOs to ensure timely execution of stability studies Monitor adherence to schedules proactively addressing any delays or issues to maintain compliance with project timelines Ensure all stability testing activities are performed in accordance with approved protocols procedures and regulatory requirements Liaison with CMOs CTOs Act as the primary point of contact for CMOs CTOs regarding stability testing activities fostering strong communication and collaboration Coordinate the transfer of stability samples protocols and related documentation between internal teams and external partners Review CMO CTO stability testing plans to ensure alignment with company standards and regulatory expectations Regulatory Compliance Ensure all stability testing activities comply with applicable regulatory requirements including FDA EMA ICH and other global standards Maintain up-to-date knowledge of regulatory guidelines related to stability testing and ensure their integration into testing schedules and procedures Support regulatory submissions by providing stability-related documentation and data as required Deviation Management Investigate and resolve deviations related to stability testing at CMOs CTOs conducting root cause analyses and implementing corrective and preventive actions CAPA Monitor the effectiveness of CAPA implemented by CMOs CTOs to ensure continuous compliance and quality improvement Document and report deviations and resolutions to internal stakeholders and management Data Management and Documentation Oversee the collection review and documentation of stability data generated by CMOs CTOs ensuring accuracy completeness and compliance Maintain robust data management practices including proper storage retrieval and archiving of stability-related documentation Support the implementation and maintenance of electronic systems e g LIMS for stability data management Collaboration and Communication Work closely with cross-functional teams including Quality Control Quality Assurance Regulatory Affairs and Manufacturing to align stability testing with project goals Communicate effectively with internal and external stakeholders providing clear updates on stability testing progress and issues Represent the stability function in meetings and discussions related to pharmaceutical development Continuous Improvement Identify opportunities to streamline stability testing processes and improve coordination with CMOs CTOs Participate in internal audits and contribute to the development and refinement of standard operating procedures SOPs for stability activities Support quality improvement initiatives related to stability testing and data management Training and Support Provide training and guidance to internal teams and external partners on stability testing procedures and regulatory requirements Support the professional development of team members involved in stability activities fostering a culture of compliance and excellence All other relevant duties as assigned Job Requirements Education Bachelor s degree in a scientific discipline e g Chemistry Biology Pharmaceutical Sciences or a related field Advanced degree or certification in Quality Control or Stability Testing is preferred Experience 3 years of experience in pharmaceutical stability programs or quality control within the pharmaceutical or biotech industry Proven experience coordinating with CMOs CTOs for stability testing or related activities Strong understanding of regulatory requirements for stability testing e g FDA EMA ICH guidelines Skills Exceptional organizational and time-management skills with the ability to manage multiple schedules and priorities Strong communication and interpersonal skills with the ability to build effective relationships with internal and external stakeholders Detail-oriented with a commitment to accuracy and regulatory compliance Effective problem-solving skills particularly in managing deviations and implementing CAPA Preferred Qualifications Experience with electronic data management systems e g LIMS Knowledge of Good Manufacturing Practices GMP and Good Laboratory Practices GLP Familiarity with stability study design and data analysis Working Conditions Office-based position with occasional travel to CMOs CTOs manufacturing sites or external partners as required Ability to work effectively across different time zones as needed