【Janssen】Manufacturing Management Senior Specialist

Overall purpose of job:

This role aims to support key compliance requirements for GQP ordinance in Japan and J&J global standards for Business Quality (BQ). The role will help ensure there is appropriate Marketing Authorization Holder (MAH) oversight of all supplying manufacturers to Japan local operating company.

Essential duties and responsibilities:

Responsibilities include, but not limited to:

1. Review consistency of the manufacturing, specifications, product release criteria and test methods with the registered dossiers in Japan at all times.
2. Review any manufacturing changes and deviations impact to MAH, Japanese customer requirements and compliance status to registered dossiers in Japan.
3. Report (escalate) any issues to the Quality Assurance Manager.
4. 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 investigations.
5. Review corrective and preventive actions related any investigations.
6. Control and monitor (where applicable) the temperature conditions during transportation, storage and distribution for all temperature sensitive products.
7. Support conduct of regular (self-) inspections that are applicable on the supply chain network within the responsibilities of the MAH.
8. Initiates and tracks Quality Agreement with Manufacturers, Contract Laboratories and Logistic Service Providers as needed.
9. Contribute to the BQ mission, vision and strategy
10. Contribute to Quality deliverables for Japan product lifecycle
11. Support GxP system (CAPA, Change Control, Deviation, Quality issue, Training etc.)
12. Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.

1. +2 years of directly related experience in quality assurance and quality related activities.
2. Preferably with basic knowledge in manufacturing process, problem solving/investigation tools, product quality and GxP audits
3. Demonstrated ability to manage relationship, development and maintenance, and negotiation skills.

Other features of the job:

Essential knowledge and skills:

1. Experience with Japanese pharmaceutical companies
2. Good communication skills both in English and Japanese
3. Good verbal and written communications skills. Must be able to effectively articulate ideas with different levels in the organization.
4. Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
5. Project management skill

Core competencies required for this role:

1. Leadership as an individual contributor to challenge the status quo and how things have always been done.
2. Motivation with high personal integrity and application of J&J Credo Values in daily operations.
3. Leadership experience leading projects, programs or other global initiatives
4. Can show his/her agility, ability to learn fast and comfort in complex environment.
5. Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders