Quality ManagerLocation Tokyo, Japan
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. Come join our team and make a meaningful impact on patients’ lives.
The Quality Manager is responsible for all Quality Assurance (QA) duties required at the Japan entity in accordance with Good Quality Practice (GQP) and Good Manufacturing Practice (GMP) for quality control, secondary packaging and visual inspection. The Quality Manager will work closely with the Marketing Supervisor General and the Safety Manager, for supporting the Japan entity on maintaining a valid Marketing Business License. And also cover the Supply Chain Management (SCM) related activities from QA manager view point.
A) Perform the duties of the Quality Manager to ensure company products, procedures and policies are in compliance with Japanese regulations, Good Quality Practices (GQP) and Good Manufacturing Practices (GMP). These duties include, but are not limited to:
- Supervise all in-country (Japan) quality assurance duties
- Establish a quality standard code for each product
- Ensure all required quality assurance duty procedures are in place and approved to conform to the standards for quality assurance
- Establish GQP agreements with all ex-country manufacturers
- Ensure drug product releases conform to Japanese regulations and the Japan marketing authorization (MA.)
- Promptly report to the Marketing Supervisor General and Corporate Quality Director any manufacturing, quality control, or product quality defects identified during product release evaluation
- Closely collaborate with and maintain a timely and open communication channel with other departments such as drug safety control /BPV, Regulatory Affairs and other departments to ensure product safety and quality
- Periodically verify the manufacturing and quality control of the Manufacturer’s of the drug product
- Change Management, to include ensuring that any proposed manufacturing, testing or specification change does not seriously impact the quality of the product
- Notify the Manufacturers in the event that any improvements to the manufacturing or quality control are required
- Ensure appropriate investigations are performed in the event of any product complaint or other reported product quality or safety concern
- Ensure appropriate procedures are in place for handling product recalls
- Perform self-inspections, including internal audits
- Ensure quality assurance personnel are appropriately trained to perform their duties
- Ensure drug product shipment and storage maintains drug product quality and safety throughout the in-country supply chain
- Ensure controlled documents are approved, distributed and maintained in accordance with GQP and established quality assurance duty procedures.
B) Other duties include:
- Review and Report results of all in-country product testing results, visual inspection and secondary packaging to the corporate quality department, as requested.
- Provide chemistry manufacturing and controls (CMC) support to corporate office to ensure all BioMarin products conform to Japan marketing authorization
- Provide support to other in-country (Japan) corporate business partnerships
- Work closely with the Regulatory Affairs department in Japan and in Global on the strategy for the region and for Japan.
EDUCATION & EXPERIENCE
- Degree in the microbiology, biotechnology or chemistry preferred
- Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations in Japan
- Overall knowledge for SCM related activities, especially cold chain products
- Knowledge of US and EU GMP and ICH guidelines
- Minimum 5+ years of related experience (i.e., GMP/GQP experience)
- Personnel management experience
- Previous experience working with or liaising with the pharmaceutical and medical device agencies (PMDA) and other administrative agencies preferred
- Strong written and verbal English language skills
- Demonstrated conversational English language skills
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.