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    Quality Manager, Japan - Tokyo, 日本 - Galderma

    Galderma
    Galderma Tokyo, 日本

    1日前

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    フルタイム
    説明

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

    We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

    At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

    Job Summary:

  • Effectively lead and implement all quality assurance requirements in the affiliate
  • Ensure Good Distribution Practices ( GDP ) per global and / or local regulations of product imported by Galderma Japan
  • Maintain Quality Management System ( QMS ) and Good Quality Practices (GQP) according to corporate and / or local regulations
  • Ensure that quality of Galderma finished products that are imported and distributed by Galderma Japan is complied with both Japan local regulation and Galderma Corporate Quality Policy (Quality policy and the relevant SOP) including GxP requirements.
  • Manage Quality operations that are impact to quality of products in accordance with the related local regulations and Galderma Corporate Quality Policy.
  • Take on the Hinseki role for Galderma products to fulfil the local regulatory requirements.
  • In this role, you will be direct reporting to Head of Quality, JPAC (solid) and Head of Japan ( dotted).

    • Responsibilities:

    Key duties and responsibilities:

  • Responsible as the Quality Representative (QR) for ensuring GDP compliance.
  • Ensure all aspects of GDP are implemented and maintained to current QMS required by global and / or local regulations.
  • Develop, maintain, and assist in the implementation of QMS and ensuring that required SOPs are established and reviewed accordingly.
  • Manage Product Quality, Complaints, Recalls, Returned products, and Counterfeits.
  • Manage third party redressing / repacking activities, and the release to the market when applicable.
  • Conduct Q/PV Management Review based on KPI data and implement the actions for improvement.
  • Report and monitor monthly KPIs.
  • Manage external inspections, internal audits and deviations according to Galderma Corporate Standard and local written procedures and implement each CAPA timely.
  • Ensure affiliate 3rd parties are qualified, maintained in an approved audit status and with Technical Quality Agreements (TQAs) established.
  • Support principal release of products received inbound including temperature excursion assessment.
  • Keep up to date with changes to regulations and standards, and ensure relevant colleagues are advised of the implications of such changes.
  • Arrange and update artworks of local packaging materials of registered products concerned by coordinating with Logistics, Regulatory Affairs, Sales, and Marketing.
  • Act as primary quality contact person with Third Party Logistics ( 3PL ) and as qualified person for internal quality compliance matters
  • If required, complete internal Auditor Qualification Training Program to be a lead auditor.
  • Conduct the Quality training for GxP related activities by planning, supporting and performing training activities.
  • Communicate and update with JPAC Quality head regularly for any quality issues occurred.
  • Authorization of product from quarantine to approve status, disposition for trade returns and damaged products.
  • Ensure local repackaging of products is performed in accordance with specifications and required licenses.

    • Others:

  • Foster and maintain good cross-functional working relationships with other departments.
  • Represent the company in the relevant committees of the professional/industry associations, if necessary.
  • Helps to ensure any non-compliance related to Galderma products is documented with proposed CAPA(s) and oversees that all CAPAs are resolved.
  • Adhere to related laws, regulations, Galderma Code of Ethics, and any other applicable Codes and SOPs.

    • Qualifications

    Experience /Competencies :

  • Minimum 5 – 7 years Quality Assurance experience in pharmaceutical and medical devices and/or cosmetic industry
  • Bachelor degree and/or above major in sciences related required and pharmacist preferred.
  • Good knowledge and understanding of GMP and GDP regulations, guidelines and policies governing the healthcare industry (pharmaceutical, cosmetic, medical device).
  • Extensive working experience with regulatory compliance inspections
  • Strategic & positive mind set & leadership.
  • Good working relationship with internal and external bodies.
  • MS office (Word, PowerPoint and Excel)
  • Experience working in an international matrix organization.
  • Good working knowledge of cosmetics and quasi drugs registration procedures and regulatory aspects in Japan.
  • Qualified Quality internal auditor.

    • Language: Proficiency in written and spoken Japanese and English

    Required pre-requisites skills for this position:

  • A good understanding of the commercial drivers of the cosmetics and quasi drugs industry and an associated ability to provide advice/guidance that takes these into consideration.
  • Analytical skills and attention to detail with the capability to appropriately define issues, questions and data.
  • Excellent communication skills: good, positive and proactive communication and the ability to foster excellent working relations with both internal, external customers and stakeholders.
  • Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills.
  • Ability to work both independently hands-on and as part of a team as required.
  • Commitment to continued improvement in department processes and performance.
  • Be a self-starter and proactively contributes to a positive team attitude and highly productive work environment
  • Driving excellent execution and consequently delivering results
  • High level of integrity and credibility
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