Manager, External Quality
Location São Paulo, Brazil Workstyle Hybrid ApplyWho 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.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
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.