Quality Associate, Quality Processes (GCP training coordinator)

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.