Associate Director, Japan Quality & Compliance
MSD
Chiyoda, Tokyo, Japan
4 日前

Responsibilities :

1. Responsible to implement Quality Assurance policy and discharge QA responsibilities (deviation management, change control, market release, complaint handling, training, audits, self-

inspections, etc.) in alignment with the GQP regulations in conjunction with and under the direction of the Director (GQP Quality Assurance Supervisor).

2. People manager to a team of quality professionals, supporting routine work activities, managing priorities, and career development.

Will exercise a leadership role in managing and inspiring an effective team.

3. Assures the team operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations (GQP, Corporate / Divisional Policies / Procedures, etc.).

4. Assures that products are produced from approved processes in conformance to all applicable regulatory requirements and Company Policies.

5. Build and maintain effective Quality Systems and proactively drive continuous improvement. Exercise analytical and scientific skills to manage activities necessary to support the Quality Systems program for the manufacturing, testing, packaging, storage, and distribution of API intermediates, API, non-

sterile pharmaceutical products, sterile pharmaceutical products, vaccines, biologics.

6. Participate in strategic initiatives for compliant supply, operationalizing quality, and developing an engaged and capable workforce.

7. Act as an interface on the Company’s behalf with regulatory agencies.

8. Manage and drive resolution of quality issues and support effective issue management with Global counterparts.

9. Coordinates significant investigations including product recalls as needed.

10. Closely collaborates, builds and maintains strong relationships with stakeholders both internal and external.

11. Ensures the quality performance of external parties through direct oversight, support and technical advice, and providing on-

site supervision as appropriate.

12. Supports Alliance Management and Business Development projects, overseeing activities such as external party selection (GMP Due Diligence), commercialization, and establishing Quality Agreements.

13. Supports various risk management assessments at external parties such as data integrity and Quality Risk Management (QRM).

Qualification / Skills :

  • BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.
  • Knowledge / Expertise in API, non-sterile / sterile products, vaccines, biologics manufacturing processes and quality systems.
  • Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities. Minimum of 8 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of GQP, GMP and regulatory requirements.
  • Current or prior experience as a people manager or team leader.
  • Must have very strong English speaking, listening, and written skills. Can independently lead discussions and drive issue resolution with Global counterparts.
  • Competent in analyzing complex product, production, testing, and regulatory issues and have demonstrated scientific problem-solving capabilities.
  • Possesses a strong compliance mindset.
  • Must have strong demonstrated interpersonal skills, including leadership and coaching, motivation, strategic communication and negotiation.
  • Some level of contractual and financial awareness is required.
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