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.
- 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