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.