Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Thermo Fisher Scientific Inc. is seeking a Quality Supervisor, to join our dedicated team in Santiago de Chile or Bogota, Colombia . As the Supervisor, Quality, you will play a key role in maintaining high-quality services and products by encouraging a Quality Culture that aligns with global policies and processes, cGMP, cGDP, and regulatory requirements. This is an exciting opportunity to contribute to our organization and uphold internal quality standards throughout the Andean Region.

Duties and Responsibilities

• Proactively lead quality processes and policies to ensure compliance with FCS quality standards in Chile, Colombia, and Peru.

• Evaluate and analyse current processes and policies for continuous improvement.

• Drive a quality culture in every sector of the organization through good practices, training, and collaboration with all areas of the organization.

• Carry out batch record approval.

• Ensure that all processes are carried out in accordance with cGMP.

• Responsible for the management of change control activities and planned and unplanned deviations.

• Responsible for the investigation of customer complaints until their resolution, when required.

• Be in direct contact with customers regarding quality issues.

• Conduct internal audits according to SOP requirements and collaborate in regulatory, supplier, and customer audits.

• Promote continuous training of staff in Quality/GMP throughout the company.

• Approve and maintain local SOPs, forms, and policies for Clinical Logistics.

• Approve and support qualification and validation of controlled areas.

• Creation and maintenance of critical metrics.

Education/Requirements

• Pharmacy ( Químicos Farmacéuticos TITULADOS )

• Qualification/s or similar experience in the area of quality assurance.

Experience/Skills

• Knowledge of IMP process, preferably with management of protocols, key customers, and business objectives.

• Auditor Experience.

• Up-to-date knowledge of regulatory standards.

• Knowledge of country logistics requirements.

• Ability to analyze problems and define solutions.

• Ability to prioritize and support others.

• Good interpersonal, verbal and written skills

Certifications or licenses

• Preferably a pharmacist ( Químicos Farmacéuticos TITULADOS )

Supervisory Responsibilities

Leading Quality Assurance team for Andean Region countries

Internal and external contacts

Internal:

• General Manager, Operations, Client Services, Finance, and Business Development.

• Other FCS sites.

• Global Warehouse Network representatives.

External:

• Client representatives of different areas.

• Suppliers representatives.

Languages

Proficiency in English is required for both written and spoken communication in technical conversations.

Capabilities or skills

• Result focus

• Continuous improvement / Analytical skills

• Partnership with other areas

• Good communication

• Customer interaction

• Decision making

Others

Availability to travel is required for this role.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.