Senior Specialist, GMP Quality Assurance, Brazil

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: On-site (full time) position in Cajamar city.

General Description:

Ensure compliant and uninterrupted supply of BeOne products in accordance with BeOne’s quality management system and Brazil´s regulatory authority expectations. Be the technical co-responsible (pharmacist) in charge of the warehouse facility.

Essential Functions:

Act as the Co-Responsible Pharmacist in Charge for the warehouse before local Health Authorities (VISA/ANVISA), ensuring full compliance with applicable Brazilian regulations

Provide Quality oversight of the Logistics Operator (3PL), ensuring that activities performed on behalf of BeOne are executed in compliance with GDP, internal procedures, and regulatory requirements

Support the maintenance and continuous improvement of the Quality Management System (QMS) related to warehouse and distribution activities

Ensure appropriate management of warehouse documentation, including procedures, records, technical agreements, and regulatory licenses

Manage deviations, CAPAs, and quality events related to warehousing and distribution activities, including root cause analysis and effectiveness checks

Oversee temperature monitoring, temperature excursions, storage conditions, and related investigations

Support product importation activities, when applicable, ensuring compliance with quality and regulatory requirements during receipt, storage, and dispatch processes Docusign Envelope ID: 779F979A-909E-4AF8-BC34-5B204845AEC3

Review of quality-relevant warehouse records, as applicable (e.g., temperature excursions, returns assessment, reconciliation documentation)

Support product recalls, including participation in mock recall activities

Provide Quality support to Supply Chain and Quality Head for logistics-related interfaces (returns, temperature excursions, complaints involving distribution, destruction of goods, etc.)

Conduct training for the Logistics Operator personnel, as required

Participate in qualification, periodic evaluation, and performance monitoring of the Logistics Operator, including KPI review and quality meetings

Support change control processes impacting warehousing and distribution activities

Participate in corporate audits, regulatory inspections, self-inspections, and regional management reviews, as required

Minimum Requirements – Education and Experience:

Bachelor’s degree in Pharmacy or Pharmaceutical Sciences, duly registered with the Regional Pharmacy Council (CRF).

Relevant professional experience to support the assigned Quality Assurance responsibilities.

3–5 years of experience in Quality Assurance within a pharmaceutical company.

Fluency in Portuguese and English (speaking, writing, listening, and technical vocabulary).

Supervisory Responsibilities: N/A

Computer Skills: Microsoft office suite, Teams, Veeva, QMS software systems

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Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork

Provides and Solicits Honest and Actionable Feedback

Self-Awareness

Acts Inclusively

Demonstrates Initiative

Entrepreneurial Mindset

Continuous Learning

Embraces Change

Results-Oriented

Analytical Thinking/Data Analysis

Financial Excellence

Communicates with Clarity