Requisition ID: 1905726636W
Associate Director – Business Quality (New Business) has the responsibility for quality & compliance oversight and governance of the newly acquired business in Japan (Ci:z Holdings Co. Ltd.). She/He will work with the Commercial, Supply Chain and R&D partners to ensure that all commercialized products of Ci:Z Holdings Co. Ltd. in Japan are fully compliant to the applicable regulatory requirements in Japan and also to the Quality Policy Standards and procedures of Johnson & Johnson. This role requires strong partnering with the cross-functional Unification team and also with the Ci:z Holdings Management Board to ensure Quality and Regulatory Compliance of all commercialized products across its lifecycle.
Scope/Responsibilities of The Role
- Lead and drive effective implementation of the Quality Management System for the newly acquired business of dermo-cosmetic products in Japan. Partner with the cross functional Unification team to identify the Quality/Regulatory risks (if any) and then ensure timely & effective remediation/mitigation of the risks. Develop and deploy near-term and long-term mitigation plans for the Post Acquisition Assessment findings by JJRC.
- Ensure ongoing and robust compliance to Japan regulations of all products of Ci:z Holdings. This includes ensuring adequacy & compliance of GQP & GMP responsibilities for all Ci:z Holdings products commercially distributed/sold in Japan.
- Regularly monitor and improve the quality systems & procedures to ensure compliance to J&J Quality Policy, Enterprise standards, Worldwide Procedures and Guidelines. Ensure periodic Quality Systems Management Review, Product reviews, Escalations, Product Assessment Meetings, Quality Review Board, Field Actions and Product Discontinuations for the Ci:z Holdings product in Japan.
- Support the LOC Leads of the ex-Japan markets globally in their preparedness for the regulatory inspections/audits of Ci:z Holdings products, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations.
- Be the Primary Quality contact for the business /commercial organizations and work with various functions within APAC (Ci:z Holdings Leadership Team, Supply Chain, Regulatory Affairs, R&D, Product Development, Marketing, CD, CLS among others) to meet business objectives.
EDUCATION: Graduate or Post-graduate degree in Science, preferably in Pharmaceutical
or Cosmetic Sciences, Chemistry or Pharmacy. Additionally, a Management
degree/diploma will be preferred.
10 – 15 years of experience in the field of Quality Operations and Regulatory Compliance
within the regulated pharmaceutical / Medical Device / Cosmetics Japanese industry.
knowledge of Japan Regulations applicable to Drug, Quasi-drug, Cosmetic, & Medical
Device products, for design, development, manufacture, supply & post-market
inspection experience with PMDA is highly desirable.
track record of Quality & Regulatory Compliance function in Multinational Pharmaceutical/
Cosmetic industry in Japan is highly desirable.
record of successful cross functional partnership and experience in working with
virtual teams in a highly matrix environment.
written & verbal communication skills in English,
besides language proficiency in Japanese is a must.
Johnson & Johnson K.K. (8235)Job Function
Quality AssuranceRequisition ID