Quality Manager

Job Description

Job Summary:

To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements.

Maintain the FCS Japan Quality System in compliance with the specified procedures, policies and requirements.

Liaise with clients, customers on quality related matters.

Duties and Responsibility:

• Ensure the required compliance to relevant internal standards, and international quality and regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain activities and drive vital improvements.
• Deliver monthly reporting on key performance indicators and provide insights, regarding trends, risks and mitigation plans.
• Provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters.
• Handle internal and external audits, and follow-up on resulting observations and opportunities for improvement.
• Mentor and develop the Quality team to deliver outstanding results.
• Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business.
• Responsible for management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.
• Ensure that a timely and effective communication and customer concern process exists to raise quality issues to appropriate levels of management.
• Leadership role in service and quality improvement initiatives in line with other functional units.

Education/Qualification:

Bachelor’s degree in life science or related medical/Pharmacy/Quality Assurance & Regulatory affair or higher

Experiences:

1. Strong QA and Production experience for 5 years+

Or

2. GMP/QMS settings in the field of quality assurance and regulatory affairs for 5 years+

Ability/Skills:

3. Knowledge of IMP process, preferably to include handling complex protocols, key clients and business objectives

4. Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies

5. Flexible and adaptable with strong customer management skills.

6. Ability to work independently under pressure and prioritize multiple tasks

7. Ability to lead and influence, and to support others within team

8. Good organizational skills

9. Good written and verbal communication skills in Japanese and English