Sr Supervisor Quality Control

y Control
Job Category:
People Leader
All Job Posting Locations:
São José dos Campos, São Paulo, Brazil
Job Description:

We are looking for a Quality Control Senior Supervisor to join our Release Laboratory team in São José dos Campos.

This key position plays a vital role in leading a team of laboratory analysts and technicians, ensuring the accurate, efficient, and compliant execution of release testing. Together, we can optimize processes and contribute to the success of our Quality Control operations.

Key Responsibilities:

• Laboratory Management: Lead all aspects of the operations of three essential laboratories: Physical-Chemical Lab, Micro Lab, and Incoming Materials Lab. Responsible for scheduling and planning activities to ensure timely completion of laboratory QC tasks. Coordinate and report KPIs and metrics in scope.

• Product Release: Manage the in-country testing of drug products, raw materials, and packaging materials while handling documentation for the release of biological and CAR-T products.

• Safety Compliance: Maintain a safe laboratory environment in line with Environmental, Health, and Safety (EHS) standards, and ensure compliance with current Good Manufacturing Practices (GMP).

• Process Improvement: Drive initiatives for continuous improvement within the laboratories to enhance efficiency and product quality.

• Investigation Support: Provide assistance for laboratory investigations concerning Out of Specification (OOS), Out of Trend (OOT), and system suitability deviations, ensuring effective resolution.

• Inspection and Audit: be the focal point for internal audits and ANVISA inspections, responsible for answering QC laboratory topics. Ensure alignment with both internal and external compliance standards.

• Documentation Oversight: Review and approve work instructions and Standard Operating Procedures (SOPs) to maintain current and reliable operational practices.

Qualifications:

Education:

• Bachelor's degree in Chemistry, Biochemistry, or a related scientific field.

Experience and Skills:

• Minimum of 8 years of quality experience in a GMP and/or ISO regulated industry, with a strong preference for pharmaceutical experience.

• Proven background in quality control or analytical laboratory environments, and solid experience with GMP requirements

• Solid understanding of analytical techniques. Experience with chromatography (HPLC, UPLC, GC), spectrometer techniques (UV, IR and NIR), dissolution, compendial methods, microbiology testing.

• Exceptional analytical thinking with a structured approach to work.

• Strong interpersonal and team collaboration skills.

• Ability to tackle challenges and address problems thoroughly.

• Demonstrated leadership and development capabilities.

• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.

• Proven ability to successfully communicate with all levels of the organization, including executive management, planning, manufacturing, and commercial teams.

Other:

• Proficiency in English is required; Spanish is an advantage.
• The position will be located in São José dos Campos, Brazil