Johnson & Johnson Careers

【Janssen】※Critical※ (Fuji) Quality Compliance Manager

Fuji, Japan
Quality (Generalist)


Job Description

Requisition ID: 1805705611W

DESCRIPTION:

 

Quality Compliance manager is a key position in the Janssen Fuji site, as he/she is ultimately responsible for ensuring the overall compliance status for all the activities performed at JPKK-Fuji. The position is also a key link between the regulatory authorities, internal and external partners leading audits and inspections.

Key responsibilities of Quality Compliance Manager are:

  • Leading the Quality Compliance team and having an oversight on all the Quality Compliance processes followed at the site.
  • Providing leadership, where required, on troubleshooting/issue resolution, etc.
  • Ensuring that all the expected Japanese regulations are complied at Fuji site.
  • Providing people leadership either directly through line leadership (his/her team) or indirectly (projects/matrix organization)
 

REGULATORY COMPLIANCE RESPONSIBILITIES:

  • Good Manufacturing Practices (GMP) – Adhere cGMP as per Japan authorities and as per Global J&J/JANSSEN Policies. 
  • EHS – Adhere to Janssen global standard related EH&S.
  • Narcotics and Psychotropic Control Law – Adhere to narcotics and psychotropic Control Law.
  • The Pharmaceutical Affairs Law – Adhere to the Japanese pharmaceutical affairs law
 
ESSENTIAL DUTIES:
<Role and Responsibilities>
  1. Leading the Quality Compliance team and have an oversight on the day to day activities done by the Quality Compliance team at Fuji site.
  2. Allocate the work to the team and ensure appropriate distribution of work throughout the team.
  3. Have an oversight of all the activities owned by Quality Compliance group. As an example – Change Control, Training, Document Control, Internal Audits etc.
  4. Perform continuous improvement of the Quality Compliance processes to make it more smart and efficient, keeping the compliance part intact.
  5. Ensure that the Quality group and eventually the entire site follows the regulatory requirement as per the Japan requirement.
  6. Lead the people training and development plans for the Quality Compliance team and ensure appropriate resources are available to manage all the activities of Quality Compliance.
  7. Maintain the budget for the Quality Compliance group and ensure that the budget is maintained within the allocated finances.
  8. Perform document review and approvals for all the applicable documents required at the site.
  9. Perform QA approval of all the validation related documents.
  10. Have close contact and communication with the other sites as well as external personnel to ensure best practices are shared and implemented.
  11. Provide guidance for compliance related activities as well as lead investigation and trouble-shooting along with initiation of appropriate CAPA to prevent the recurrences.
  12. Perform risk assessment for any change items and decide all actions related to validation and qualification. 
  13. Provide compliance as well as regulation related training and consultation to relevant department.
  14. Have a responsibility to lead and actively participate in GMP audit by Regulatory Authorities. Prepare and participate in the Internal and Janssen Global audits. 
  15. Connect and collaborate with Business Quality on a routine basis for exchange of information. Ensure the regulatory notifications are handled as per the procedure in the Fuji site.
  16. Perform global projects as required by the business and needs.
  17. Build strong relationships with global, regional and local organizations that are relevant to Quality Assurance and Compliance.
  18. Be qualified as security pharmacist as per the requirements of Janssen Japan.
  19. Support in handling of controlled substances as required.
 


Qualifications

EDUCATION/EXPERIENCE: (Essential)

  1. This position requires the candidate to be a pharmacist or at the minimum Master or Bachelor’s in science (minimum)
  2. 3 to 5 years of Quality Assurance / Quality Control / Production experience in the industry.
  3. Should have experience of leading a team of minimum 5 people
  4. Should be well versed in English communication, besides being able to converse in Japanese.
  5. Should have experience of being a team player and maintain an excellent relationship between the cross functional teams within the site, wider organization as well as with the external partners
EDUCATION/EXPERIENCE: Desirable)
  1. At least 5 years of experience in a manufacturing facility function, with at least 3 years in Quality Assurance function
  2. Working with diverse culture is desirable
COGNITIVE SKILLS:
 
  1. Strong Ability to think and approach situations in a logical manner.
  2. Strong Ability to take risk based on a logical approach/methodical thinking.
  3. Strong Ability to influence others and capability of conflict management.
  4. Ability to provide training on Japanese Regulatory Requirement.
  5. Strong knowledge and know-how of the Japanese Regulations.
  6. Strong Ability to operate in a diverse and ambiguous environment.
  7. Ability to think strategically.
  8. Ability to communicate in a clear, concise manner.
  9. Ability to look for win-win situations.
  10. Fluent in English and in Japanese.
 


Primary Location
Japan-Shizuoka-Ken-Fuji-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Quality (Generalist)
Requisition ID
1805705611W