Johnson & Johnson Careers
【Janssen】※Critical※ (Fuji) Quality Compliance Manager
Requisition ID: 1805705611W
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
Key responsibilities of
Quality Compliance Manager are:
the Quality Compliance team and having an oversight on all the Quality
Compliance processes followed at the site.
leadership, where required, on troubleshooting/issue resolution, etc.
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)
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.
and Psychotropic Control Law – Adhere to narcotics and psychotropic Control
Pharmaceutical Affairs Law – Adhere to the Japanese pharmaceutical affairs
＜Role and Responsibilities＞
- Leading the Quality Compliance team and have an
oversight on the day to day activities done by the Quality Compliance team at
- Allocate the work to the team and ensure appropriate
distribution of work throughout the team.
- Have an oversight of all the activities owned by
Quality Compliance group. As an example – Change Control, Training, Document
Control, Internal Audits etc.
- Perform continuous improvement of the Quality
Compliance processes to make it more smart and efficient, keeping the
compliance part intact.
- Ensure that the Quality group and eventually the
entire site follows the regulatory requirement as per the Japan requirement.
- 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.
- Maintain the budget for the Quality Compliance group
and ensure that the budget is maintained within the allocated finances.
- Perform document review and approvals for all the
applicable documents required at the site.
- Perform QA approval of all the validation related
- Have close contact and communication with the other
sites as well as external personnel to ensure best practices are shared and
- Provide guidance for compliance related activities as
well as lead investigation and trouble-shooting along with initiation of
appropriate CAPA to prevent the recurrences.
- Perform risk assessment for any change items and
decide all actions related to validation and qualification.
- Provide compliance as well as regulation related
training and consultation to relevant department.
- Have a responsibility to lead and actively
participate in GMP audit by Regulatory Authorities. Prepare and participate
in the Internal and Janssen Global audits.
- 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.
- Perform global projects as required by the business
- Build strong relationships with global, regional and
local organizations that are relevant to Quality Assurance and Compliance.
- Be qualified as security pharmacist as per the
requirements of Janssen Japan.
- Support in handling of controlled substances as
- This position
requires the candidate to be a pharmacist or at the minimum Master or
Bachelor’s in science (minimum)
- 3 to 5 years
of Quality Assurance / Quality Control / Production experience in the
- Should have
experience of leading a team of minimum 5 people
- Should be
well versed in English communication, besides being able to converse in
- 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
- At least 5
years of experience in a manufacturing facility function, with at least 3
years in Quality Assurance function
- Working with
diverse culture is desirable
- Strong Ability to think and approach situations in a logical manner.
- Strong Ability to take risk based on a logical approach/methodical
- Strong Ability to influence others and capability of conflict management.
- Ability to provide training on Japanese Regulatory Requirement.
- Strong knowledge and know-how of the Japanese Regulations.
- Strong Ability to operate in a diverse and ambiguous environment.
- Ability to think strategically.
- Ability to communicate in a clear, concise manner.
- Ability to look for win-win situations.
- Fluent in English and in Japanese.
Janssen Pharmaceutical K.K. (7195)Job Function
Quality (Generalist)Requisition ID