Why Patients Need You 

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.   

What You Will Achieve 

Pfizer has a scientific, ethical, regulatory and legal obligation to collect and evaluate safety information that may be associated with its products, as well as ensuring data privacy. In your role, you'll be working with a team that implements and manages the risk strategy, utilizing audit and inspection intelligence to identify risk mitigation strategies and adherence to GCP in clinical trial trials in order to assure the quality and integrity of generated data and the rights and welfare of patients. 
 

Role Summary

The main responsibility of Japan Market Lead is to lead a team of SCMOQ professionals in Japan.  The Japan Market Lead is responsible for ensuring the establishment and maintenance of an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCOs). This is essential to ensure compliance with Pfizer Quality Standards and Regulatory Authority expectations. 

The Japan Lead will be responsible as the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the Pfizer Country Offices (PCO). The Japan Market Lead will be interacting with the relevant local stakeholders.

Role Responsibilities

• Take Lead in Good Quality Practice (GQP) activities in the market and accountable and responsible for Distribution of compliant products in Japan.

• Conducting Market release of imported products for the market, by collating, reviewing, and making available all relevant documents and records available in a timely manner to the markets and in compliance with market regulatory requirements and Pfizer procedures, prior to distribution/sale within the country.

• Develop and implement the strategy for effective and efficient quality and compliance systems are in place.

• Ensuring appropriate resources are in place and are effectively organized to support the timely and compliant release for sale activities.

• Developing, implementing, and continuously improving quality systems that assure compliance with Pfizer and regulatory requirements, enhance quality, and mitigate risks.

• Monitoring Key Performance Indicators (KPI) of the quality Management Systems, evaluate and highlight any significant trends and identify actions.

• Leading the preparation and coordination of Product Quality and Good distribution practice audits and inspections of the PCOs.

• Working collaboratively with other functions and groups within a Global Business Units to enable product supply.

• Lead the identification and initiation of continuous process improvements to enhance the quality of operations, systems and services evaluating compliance with applicable GMP/GDP requirements. 

• Lead/Participate on cross functional projects teams and share knowledge and best practices.

• Coordinating and promptly performing any recall operations for medicinal products

• Set expectation for goal setting, ongoing assessment, coaching, performance development and evaluation to motivate direct and indirect reports to develop and maintain a team of highly qualified and diverse personnel that deliver results for department or business line.

• Development and Maintenance of Quality Culture, within the team and organization

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Qualifications

Must-Have 

• A minimum of 10 years in the pharmaceutical industry, preferably in a quality role

• Thorough knowledge and understanding of the technical regulatory and commercial aspects of pharmaceutical products.

• People Management Experience.  

• Experience in pharmaceutical Affairs Law, GMP, GQP /GDP and QMS.

• Fluent in English and Japanese (Both verbal and written)

• Able to work well in a matrix organization set up and influence key stakeholders. Good interaction and clear communication skills with multiple stakeholders.

Nice-to-Have 

• Master’s degree and relevant pharmaceutical experience. 

• Leadership experience supporting individual development to maximize each colleague’s potential and recognizing individual and team performance through full use of available processes including mission awards, site communications and individual recognition. 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.