Quality Associate, Quality Processes (GCP training coordinator)

Job description

Accountabilities: Support colleagues and functional teams in developing, managing, implementing, and maintaining controlled procedures. Support GxP activities to ensure compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO requirements. Provide guidance to internal teams on procedures and requirements related to GxP Quality Operations and training when required. Coordinate and support GxP training activities, helping ensure employees receive the training required to meet global regulatory expectations and client requirements. Track GxP training activities through completion and contribute to ensuring training programs are efficient, effective, and appropriately documented. Partner with Learning and Development teams to support the creation and improvement of effective GxP training programs. Assist with the triage and management of access to the Quality Management System and controlled systems. Ensure access requests for employees and clients are accurately managed and processed. Participate in projects designed to improve the efficiency, usability, and management of the Quality Management System. Support business continuity activities across the organization. Provide Quality and functional teams with reports, procedures, and relevant documentation needed for audits and inspections. Support the preparation and analysis of Quality Operations and Training metrics, dashboards, and periodic management reports. Assist with the preparation of CAPA and deviation records related to controlled documents, GxP training, or business continuity processes. Contribute to a collaborative, high-performing quality culture across global teams and regions. Support coaching, knowledge sharing, professional development, and succession planning activities as appropriate. Requirements: University degree in Biomedical Sciences, Natural Sciences, Health Sciences, Nursing, Pharmacy, or a related scientific discipline; a Bachelor’s or Master’s degree is preferred. Relevant professional experience may be considered in place of a directly related academic background. Understanding of GxP principles and regulated clinical research environments, with familiarity with applicable standards and guidelines such as ICH, CIOMS, and ISO. Experience or strong interest in GxP training coordination, quality processes, quality systems, controlled documentation, or compliance operations. Strong organizational and administrative skills, with excellent attention to detail and the ability to manage multiple activities and deadlines. Ability to maintain accurate training records, quality documentation, access requests, metrics, and reports. Strong written and verbal communication skills, with the ability to collaborate effectively with Quality, Learning and Development, and functional teams. Ability to work effectively with stakeholders across different functions, regions, and time zones in an international environment. Analytical and problem-solving skills, with the ability to identify process gaps and contribute to continuous improvement initiatives. A proactive and collaborative approach, with the ability to take ownership of assigned activities and provide reliable follow-through. Ability to support audit, inspection, business continuity, CAPA, and deviation-related activities is an advantage. Commitment to maintaining high standards of quality, compliance, confidentiality, and professional integrity. Benefits: Opportunity to contribute to meaningful clinical research and quality activities that support the development of therapies for patients. Exposure to complex clinical trials and regulated GxP processes within an international environment. Collaboration with global Quality, Learning and Development, and functional teams across multiple regions. Opportunities to develop expertise in GxP training, quality systems, compliance, and clinical research operations. Supportive and collaborative working culture focused on professional growth and knowledge sharing. Opportunities to contribute to continuous improvement and operational efficiency initiatives. Exposure to audit, inspection, business continuity, CAPA, and quality management activities. International working environment with opportunities to collaborate across North America, South America, Europe, Asia, and Australia. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Associate, Quality Processes (GCP Training Coordinator) based in India. This role supports quality operations and GxP training activities within a global clinical research environment focused on complex clinical trials. You’ll help ensure employees receive appropriate GxP training and that training activities are delivered efficiently, accurately, and tracked through completion. The position also contributes to controlled procedures, Quality Management System activities, business continuity, audit support, and quality reporting. You’ll collaborate with Quality, Learning and Development, and functional teams across international regions. The role offers exposure to regulated clinical research processes and the opportunity to strengthen compliance and operational quality. It is well suited to a detail-oriented professional who enjoys coordinating processes, working with data, and supporting a strong quality culture.