Quality Assurance Manager

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Manager of Quality Assurance conducts the works in accordance with regulations (Drug and Medical Devices act, GQP ordinance etc.) and Global role of quality management system based on experiences of Quality (Pharmaceutical QA, QC, Manufacturing etc).

The main responsibilities may include, but are not limited to

• creation and maintenance for  Quality Standard code.
• management  for Quality agreement between manufactures etc.
• review of documents and records for marketing release.
• audit to manufactuers, suppliers etc. (GQP,GMP, GDP etc) for local and oversea sites.
• change control and deviation control
• handling for complaints and non-conformance
• creation and maintenance of SOPs (Local regulation and Global requirements)
• Self-inspection
•  management of Training
• document and record control
• other quality control related jobs
• communication between global Quality teams and external suppliers for quality matters.

Integrating CARE

• Collaborative: Creating and maintaining a motivating environment for all team members.
• Cross-functional communication: Being able to collaborate and handle tasks in complex reporting lines (local and regional).
• Accountable: Updating upper management on a regular basis and keeping a regular and reliable communication flow.
• Respectful: Trusting and reliable sparring partner for both management and colleagues
• Engaged:  within Sobi community, sharing best practices, implementing new Sobi policies, following up on SobiCareer activities.

Education/Learning Experience/Work Experience

Required:

• 3+ years experiences in Quality (GMP and/or GQP) for pharmaceutical products.
• Knowledge of Japanese law and regulations such as Drug and Medical Devices act, GQP, GMP and GDP.
• Strong English communication
• Experience of manufacturing control and quality control.
• Customer focus mind-set and provide effective solutions to others.
• Good verbal and written communication skills (both Japanese and English)
• Good business and reporting skills
• Communication and Team work skills

Desired:

• Pharmacist
• Experience of QA Manager

Skills/Knowledge/Languages

Required: 

• Japanese as mother tongue, and Fluent in English, verbal and written, at the level of TOEIC score higher than 730 .
• Computer literate, with good working knowledge of Microsoft Office and the ability to learn Sobi system as required
• Understanding of handling confidential information

Personal Attributes

Required:

• Service minded with a high drive and accountability
• Good team player and network builder, but also capable of managing tasks independently
• Good communication and interpersonal skills
• A “doer” with a delivery mind-set, flexible, ready and able to exercise initiative
• Ability to multi-task and to operate efficiently in a fast moving environment also when under pressure
• Ability to prioritise among tasks with tight deadlines
• A willingness to learn
• Good attention to detail
• Maintain a professional approach, with a high degree of integrity in all interactions, externally as well as internally

This role will be office based with the possibility to work from home in agreement with the line manager. Candidates need to be flexible to travel to business meetings and support Sobi activities at international and regional meetings.