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

Job description

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＞
·  Leading the Quality Compliance team and have an oversight on the day to day activities done by the Quality Compliance team at Fuji site.
·  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 documents.
·  Have close contact and communication with the other sites as well as external personnel to ensure best practices are shared and implemented.
·  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 and needs.
·  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 required.

Desired profile

Qualifications

EDUCATION/EXPERIENCE: （Essential）

·  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 industry.
·  Should have experience of leading a team of minimum 5 people
·  Should be well versed in English communication, besides being able to converse in Japanese.
·  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）
·  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

COGNITIVE SKILLS:

·  Strong Ability to think and approach situations in a logical manner.
·  Strong Ability to take risk based on a logical approach/methodical thinking.
·  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.

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