Quality ManagerLocation Tokyo, Japan Workstyle Open to Hybrid Apply
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 support of Quality Assurance (QA) and Quality Control (QC) activities specifically to Japan and also in the APAC region. The 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;
- Partner management;
- Perform administrative quality activities
- Support investigation in deviations and complaints
Specifically to Japan, the Quality Manager is responsible for all QA duties required at the Japan entity in accordance with Good Quality Practice (GQP) and Good Manufacturing Practice (GMP) for QC, secondary packaging and visual inspection.
This position will ensure the Japan entity on maintaining a valid Marketing Business License. In addition, this position will cover the Supply Chain Management (SCM) related activities from QA 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.
- 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.
Key responsibilities include:
- Provide partner management and oversight of quality systems and programs
- Assess risk level of partner and provide Quality oversight
- Supports market planning processes
- Supports Product Complaint investigations and summaries
- Support drug product Market Release, including temperature reviews of shipments to countries.
- QA representative and liaison to CMOs and business partners
- Contribute to department goals/initiatives and manage mid-level/large cross-functional projects for the department
- Contribute to department goals/initiatives and manage mid-level/large cross-functional projects for the department. Collaborate with key stakeholders in projects to establish global standards and policies where appropriate.
- Perform technical review and approve External Quality SOP’s, WI’s, specifications, protocols, change controls and deviations, as applicable.
- Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations
- Drive implementation of a science and risk-based Quality Culture throughout the External Quality
- Develop and implement a quality system, in line with applicable regulatory requirements
- Develop and improve systems/processes to support commercial and clinical product for QA release and other activities
- Assist with regulatory inspections and regulatory requests for submissions/filings
- Other duties assigned
- 10% traveling required to partners
SKILLS and KNOWLEDGE
The ideal candidate will have the following skills:
- Partner Oversight – Understand risk management and able to assess health of a partner and work with multiple partners. Experience with collaborating with partners to mitigate and improve control strategy for clinical and commercial products.
- Decision Making/Problem Solving – Identifies problems and be able to lead and handle complex situations (e.g. major investigations). Collect input from key stakeholders in making sound and effective decisions and ensure the solutions and approach are aligned within and across teams. Be decisive and move to action in the absence of clear information. Be proactive in implementing process improvements.
- Influence and Collaboration – Success in working in a matrixed organization and work with different time zones. Demonstrates effective communication and interpersonal skills that brings cross functional teams together to reach a shared goal. Possesses strong verbal and written communication skills and the ability to influence at all levels.
- Agility – Ability to pivot quickly and recover constructively from setbacks, while continually learning and modifying approach.
- Leadership - Ability to interact with and provide leaders with guidance and recommendations to assist with decision making. Ability to facilitate meetings, influence stakeholders, and manage teams effectively in projects and goals.
- Quality Systems/GMP/Regulations - Working knowledge of GMP Quality Systems and cGMP Regulations (e.g., deviations, change controls, lot release, annexes).
- Degree in the microbiology, biotechnology, chemistry or equivalent, in a technical discipline is required
- Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations in Japan
- Knowledge of GMP compliance inspection for JNDA
- 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 10+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
- Previous experience working with or liaising with the pharmaceutical and medical device agencies (PMDA and APAC region Health Authorities) and other administrative agencies preferred
- Partner oversight, risk and project management
- Demonstrated conversational English language skills
- Strong written and verbal English language skills preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.