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HC QA Change Control and Risk Management Supervisor

Primary Location CARRERA 85 D #51-65 BODEGAS, BOGOTA, Colombia , 110821 Job ID R24016609

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Job Description:

JOB DESCRIPTION:

The QA Change Control and Risk Supervisor for the Quality Support Center (QSC) oversee the roles and responsibilities of the change control and risk programs within the QSC. He/She communicates the quality policy and objectives and ensures potential changes and associated risk(s) are implemented and maintained in alignment with healthcare guidelines (e.g., cGMP, GDP, GMP) and ISO 9001/ISO 13485 requirements. As a subject matter expert (SME) of change controls and risk management, this role coordinates and supports the field Quality Team in the impact assessment, action plan creation relating their area of responsibility. This role assess trends and communicates of the Change Control and Risk Programs to the Quality Leadership Team. This role manages specialists.

Responsibilities and Duties

  • Develop and manage changes and risk records in alignment with the quality policy and processes for consistent change management practices.
  • Provide training, support, and developmental opportunities to direct reports.
  • Develop set of criteria for trending of change controls and risk records to assist with performance trending.
  • Manages the coordination of high and medium impact change control activities (as appliable).
  • Manage any escalated changes and/or risk records to ensure adequacy and thoroughness of regional impact assessments.
  • Communicate recommendations to the appropriate Quality teams for final processing of the changes if required.
  • Support the local Quality Team for high impact / risk changes that potentially impact the Change Control or Quality risk standards.
  • Assess and approve changes related to all applicable processes and projects.
  • Evaluate all data related to created changes and effectively communicate follow up steps with the different stakeholders.
  • Participate in regular internal and external meetings and management reviews for area of responsibility.
  • Manages resources and people processes (e.g., Performance Management, Career Development, Training, Staffing, etc.) to ensure the day-to-day administration of processes and formal procedures.
  • Manages reviews of policies, procedures, regulations, and specific work instructions.
  • Provides direction and coordination to his/ her team and coordinates regular training(s) related to change controls and risk management.

Preferred Competencies

  • Knowledge of the different (Country) regulations and ISO 9001/ ISO 13485 standards is preferred.
  • Advanced English
  • Strong analytical and people management skills.
  • Good knowledge of a Quality Management System and electronic Management System (eQMS).
  • Good knowledge of Microsoft Office (Excel, Word, Outlook, Access).
  • Ability to create networks and collaborate with various internal and external stakeholders.
  • Ability to prioritize decisions which may have a significant risk for the company.
  • Identify potential gaps in the processes and make recommendations for possible improvements.
  • Strong time management skill, able to work within time-limits (deadlines).

MINIMUM QUALIFICATIONS

  • Bachelor's Degree (or internationally comparable degree) – Preferred
  • Bachelor's Degree (or internationally comparable degree) – Science or related discipline – Preferred
  • A minimum of 3 years’ experience in healthcare industry in a Quality role.

Grade: 20E

Location: Bogotá

Deadline to apply: Monday 17th June, 2024.


Employee Type:

Permanent


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