QA Senior Specialist
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 QA Sr. Specialist is responsible for support of Quality Assurance (QA) and Quality Control (QC) activities specifically to Japan and also in the APAC region. The Sr. Specialist/Quality Manager interacts with partners that act as Marketing Authorization Holders of BioMarin products to accomplish Quality Technical Agreement (QTA) activities.
In general, the main areas of activity are:
- Support Marketing Authorization Holders with local/APAC 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
A) Perform the duties of the Sr. Specialist/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.
- Review and report results of all in-country product testing results, visual inspection and secondary packaging to the corporate quality department, as requested.
- Work closely with the Regulatory Affairs department in Japan and in Global on the strategy for the region and for Japan.
- Review artwork of all products and approve in Art Work System.
- Perform temperature data review during transportation from foreign manufacturing site to Japan
- Work with chemistry manufacturing and controls (CMC) to inspect for consistency between Marketing Approval Document and Manufacturing Practice.
- Ensure all required documents are prepared for new product launching and work with a CRO to ensure GMP compliance inspection after the submission of regulatory application to the authority.
- Degree in the microbiology, biotechnology or chemistry preferred
- Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations in Japan
- Knowledge of GMP compliance inspection for JNDA
- Good to have general technical knowledge of GMP compliance inspection for the APAC region
- 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 preferred
- Previous experience working with or liaising with the pharmaceutical and medical device agencies (PMDA and APAC region Health Authorities) and other administrative agencies preferred
- Demonstrated conversational English language skills
- Strong written and verbal English language skills preferred