Johnson & Johnson Careers
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【Janssen】Business Quality Manager
Requisition ID: 1700190501W
<Responsibilities include, but not limited to:>
- Ensure consistency of the manufacturing, specifications and test methods with the registered dossiers in Japan.
- Lead corrective and preventive actions to maintain compliance status with the registered dossiers in Japan.
- Maintain Quality Agreement with External Manufactures, Contract Laboratories and Logistic Service Providers as needed
- Contribute to the BQ mission, vision and strategy
- Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
- Support GxP system (CAPA, Change Control, Deviation, Quality issue, Training etc.)
- Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.
- Implement a documented process to control and monitor (where applicable) the temperature conditions during storage and distribution for all temperature sensitive products.
- Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.
- Conduct regular (self-) inspections that are applicable on the supply chain within the responsibilities of the LOC.
- Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.
- +7 years of directly related experience in quality assurance and quality related activities., or Johnson & Johnson
- Experience with Japanese pharmaceutical companies
- Excellent communication skills both in English and Japanese
- Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
- Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
- Project management skill
- Advanced degree (MS, MBA, PhD) preferred
it is preferred
- Have experience in manufacturing, product quality, CMC, RA or GXP audit
- Have a pharmacist’s license
- Leadership to challenge the status quo and how things have always been done.
- Leadership and motivation with high personal integrity and application of J&J Credo Values in daily operations.
- Leadership experience leading projects, programs or other global initiatives
- Can show his/her agility even in a new work area.
- Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders
Janssen Pharmaceutical K.K. (7195)