quality assurance manager/ quality specialist (cmo management).

Responsibilities include, but not limited to:Creates QMS and GQP operating procedures per the Pharmaceutical Medical Devise Affairs Law - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices; and small molecules in solid oral dosage formLeading projects such as tech transfer for export products to CMO as a Quality.Contributes to Quality deliverables for Japan and/or Export countries product launches, lifecycle events and other commercialization activitiesManage GxP system (CAPA, Change Control, Deviation, Self-inspection, Training, Complaint, Recall, etc.)Quality oversight of Contract Manufactures mainly, and Contract Laboratories and Logistic Service Providers as neededContributes implementation of Quality Management System and Standard Procedures per ICH Q10 and PAL; to include Information Systems and GMP ProceduresContributes the GMP Intelligence Program to assess and monitor Japanese and export countries’ regulations, standards and guidance documents related to GxP, product testing and Japanese and/or export countries’ Pharmacopoeia requirements

求められる経験
Basic Qualifications

Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities.

Demonstrated ability to manage relationship development and maintenance and negotiation skills.

Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers.

Pharmaceutical/ Biologics product commercialization and lifecycle management experience

Knowledge of regulatory authority inspection processes

Experience in Japan with multiple language capability (English, Japanese)

Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.

Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff

Ability for travel to international destinations as needed

Preferred Qualifications

Leadership experience leading teams, projects, programs or directing the allocation of resources

Experience with Japanese pharmaceutical companies

Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan

Experience with commercial products

Experience with medical devices in Japan

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,000 ～ 1,200万円

賞与
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