Manager, External Quality

Há 3 dias

São Paulo, Brasil BioMarin Tempo inteiro

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 1997, 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

RESPONSABILITIES
- 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.

  • Quality Manager

    1 semana atrás

    São José dos Campos, Brasil Johnson & Johnson Tempo inteiro

    For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s...

  • Quality Manager

    Há 6 horas

    São José dos Campos, Brasil Johnson & Johnson Tempo inteiro

    For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.Our diverse workforce and culture of belonging accelerate innovation to solve the world's most...

  • Quality Manager

    2 semanas atrás

    São José dos Campos, SP, Brasil Johnson & Johnson Tempo inteiro

    For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s...

  • Manager, External Quality

    3 semanas atrás

    São Paulo, Brasil Biomarin Tempo inteiro

    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...

  • Specialist - External Quality Assurance

    Há 4 dias

    São Paulo, Brasil Nexcella, Inc. Tempo inteiro

    Specialist – External Quality AssuranceSão Paulo, Brazil / RemoteNexcella, Inc.Our 3 Core Values- Intelligence- Integrity- InitiativeOur mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures.Patients are waiting!What You'll Do:The Specialist, External Quality Assurance (EQA) will...

  • Specialist - external quality assurance

    4 semanas atrás

    São Paulo, Brasil Nexcella, Inc. Tempo inteiro

    Specialist – External Quality Assurance São Paulo, Brazil / Remote Nexcella, Inc. Our 3 Core Values • Intelligence • Integrity • Initiative Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting! What You'll Do: The Specialist, External Quality...

  • Quality Manager Latam

    Há 6 dias

    São Paulo, Brasil Novo Nordisk Tempo inteiro

    Quality Manager LATAM **Category**:Quality **Location**:São Paulo, São Paulo, BR **The Position** - As a Quality Manager LATAM, you will: - Contribute to the development of the LATAM GDP (Global Distribution Practice) Audit strategy for external suppliers. - Lead the auditor's team in the business area. - Oversee the GDP external audit process,...

  • External Operations Quality Manager

    Há 6 dias

    São Paulo, Brasil Wella Company Tempo inteiro

    **Function**:Supply Chain **Location**:Sao Paulo, SP, BR **Work Arrangement**:Hybrid **ABOUT THE WELLA COMPANY** Together, **WE** enable individuals to look, feel, and be their true selves. Wella Company is one of the world’s leading beauty companies, comprised of a family of iconic brands such as Wella Professionals, Clairol, OPI, Nioxin and ghd....

  • External Quality Assurance, Specialist

    2 semanas atrás

    Sao Paulo, Brasil Organon Tempo inteiro

    **Job Description**:Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon...

  • Quality Manager

    1 semana atrás

    Sao Paulo, Brasil Equação IT Tempo inteiro

    Equação IT is a company focused on boosting technology and solid solutions through our expert consultants leading a high perspective and adding value to our customers with the purpose of providing optimization and business growth to our partners. We are looking for a Quality Manager with the following requirements: Functional Description: - Will lead and...