Manager, External Quality

Biomarin; São Paulo; Presencial; BRL 120.000 - 160.000; Tempo integral

Resumo da oferta

A biotechnology company is seeking a Manager for Quality Assurance in the LATAM region, responsible for monitoring and supporting partners with regulatory requirements and ensuring documentation compliance. The ideal candidate is a pharmacist or equivalent with at least two years of leadership experience in quality assurance and fluency in English, Portuguese, and/or Spanish. This role offers opportunities to engage in various administrative and operational activities related to quality control and compliance.

Qualificações

• Quality Assurance leader with more than 2 years of experience.
• Experience in validation and qualification for more than 2 years.
• Document management experience in GMP for more than 2 years.

Responsabilidades

• Control documentation including SOPs in local language.
• Review lot release documents before MA Holder release.
• Monitor regional requirements for MA holder licensing.
• Support operational activities at LATAM warehouse.
• Assist in the investigation of deviations.

Conhecimentos

Fluent in English

Fluent in Portuguese

Fluent in Spanish

Leadership

Quality Assurance

Formação académica

Pharmacist graduated or equivalent

Descrição da oferta de emprego

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in ****, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

About Technical Operations

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

SUMMARY

The Manager is responsible for support quality assurance and quality control activities in the Latam region. Interact with partners that act as Marketing Authorization Holders of Biomarin products to accomplish Quality Technical Agreement (QTA) activities. Support qualified person in LATAM region. The main areas of activity are:

• Support Marketing Authorization Holders with local regulation requirements;
• Monitor DP release by MA holders in the region and documentation related;
• Monitor and support partner communications;
• Perform administrative quality activities
• Support investigation in deviations and complaints

RESPONSIBILITIES

• Documentation control including SOP in local language, training records, contract, work instruction and archiving;
• Review lot release documents before MA Holder responsible person release, where required;
• Monitor regional requirements for MA holder licensing;
• Support operational activities at applicable LATAM warehouse
• Process services execution and payment (maintenance, translation, lab services, calibration, qualification, authorities fee, reagents, etc.)
• Support local investigation of temperature deviation and complaint;
• Support method transfers as needed
• Periodic review of QTA and execution verification
• Perform other duties as assigned

EXPERIENCE AND EDUCATION

• Pharmacist graduated or equivalent, fluent in English, Portuguese and/or Spanish language
• Quality Assurance leader; more than 2 years in leadership;
• Validation and qualification experience; more than 2 years
• GMP Document management; more than 2 years
• Batch release; more than 2 years
• Ability to effectively train others

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.