Company

◆グローバルランキング15位以内

◆福利厚生充実且つ、離職率も業界水準よりも低め

◆豊富なパイプラインとコンパウンドを持っており、今後もスペシャリティケア領域を中心に増

◆フレキシビリティの高い働き方を推奨し、定年後も再雇用実績あり

Job Description

Responsibilities include, but not limited to:

Establishes drug GQP and device QMS operating policies per the Pharmaceutical Affairs Law - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices; and small molecules in solid oral dosage form
Contributes to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
Accountable for the compliance, Policies and Procedures, and government regulations
Provides guidance and technical advice for PMDA Inspections, as needed
Quality oversight of Contract Laboratories, Distributors and Logistic Service Providers as needed
Oversight of the CMO
Accountable for implementation of Quality Management System per ICH Q10 and PAL; to include Information Systems, GMP Procedures and Policies and Training Curriculum
Quality oversight and Audit program management for key Japanese suppliers to the company. These suppliers may include final packaging materials suppliers and service providers.
Development and management of the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to it, product testing and Japanese Pharmacopoeia requirements; as delegated, represent the key industry groups in Japan and provide the stakeholders with guidance and interpretation on these requirements.

Basic Qualifications

Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities in a global commercial operation.
Demonstrated ability to effectively manage a partnership alliance, including relationship development and maintenance, negotiation skills and oversight to monitor health of partnership
Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers.
Pharmaceutical/ Biologics product commercialization and lifecycle management experience
Strong verbal and written communication skills in English and Japanese.
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 all 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

Quality Assurance Sr Mgr