This position reports to the Associate Director of In Market Quality (HINSEKI/ Quality Assurance Supervisor) within the External Quality organization and will maintain responsibility, oversight, and management of quality-related activities for drug product releases to Japan and APAC region as required.

As part of the External Quality team, the responsibilities consist of maintaining the compliance profile and quality mindset including planning, implementation, project management and management of applicable Quality Systems and oversight of partners. The manager will work closely with peers in a team-matrix environment to have proper oversight of all the partner(s).

The Quality Assurance Manager is responsible for the support of Quality Assurance (QA) and Quality Control (QC) activities specifically to Japan as required by GQP ordinances and the APAC region. The Quality Assurance Manager interacts with partners that act as Marketing Authorization Holders of BioMarin products to accomplish Quality Technical Agreement (QTA) activities and provide QA support to Supply chain Management (SCM) related activities.

This position will be based in Tokyo, Japan and will require travel.

RESPONSIBILITIES

List the major responsibilities of the job.

The Quality Assurance Manager reports to Associate Director of In Market Quality (HINSEKI/Quality Assurance Supervisor) and is responsible for 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.

A) Support Associate Director of In Market Quality (HINSEKI/Quality Assurance Supervisor) all in-country (Japan) quality assurance duties Perform the duties of the Quality Assurance Manager to ensure company products, procedures and policies are in compliance with Japanese regulations, Good Quality Practices (GQP), Good Manufacturing Practices (GMP) and BioMarin’s Global procedures.  These duties include, but are not limited to:

• Establish/maintain a quality standard code for each product
• Ensure required quality assurance duty procedures are in place and conform to the standards for quality assurance
• Establish/maintain GQP agreements with ex-country manufacturers
• Ensure drug product releases conform to Japanese regulations and the Japan marketing authorization (MA)
• 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
• Leads 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 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
• Work closely with the Regulatory Affairs department in Japan and in Global on the strategy for the region and for Japan
• 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
• 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).

SCOPE

Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.

This position is needed to assure continuity business of Marketing Authorization Holders of Drug Product in the region that have responsibilities to follow local requirements, regardless of the responsibilities of Distribution partner.

EDUCATION

State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

• 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

EXPERIENCE

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

• 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

EQUIPMENT

Describe any equipment required to perform the job.

Standard Company assigned equipment