Specialist, Quality Systems & Compliance

Warner Bros. Discovery (Tokyo, 日本) フォロー 8日前

今すぐ適用する

Job Description

Main Responsibilities:

Support the Quality Assurance activities of the Marketing Authorization Holder as described below:

Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all applicable regulations.
Establish and maintain robust local procedures to support GQP operations.
Manage and work closely with manufacturing sites to ensure effective and robust Quality Management Systems are in place.
Manage manufacturing site deviations, significant investigations, and change controls as the Marketing Authorization Holder via strong collaboration with Operations and Technical functions including Global functions.
Support change control activities associated with regulatory filing updates and new product filings and launches.
Support routine GMP audits of manufacturing sites including gap remediation.
Support the review of Annual Product Reviews of manufacturing sites.
Support compliance activities associated with Japan Pharmacopeia and other compendial updates and changes.
Support Quality and Compliance activities associated with regulatory requirements and regulatory notices.
Conduct Quality due diligence activities for pre-approval of new external partners.
Support Quality activities and engage with external partners for various business deals.
Support GQP regulatory inspections for Marketing Authorization license renewal.
Collaborates cross-functionally with stakeholders including Regulatory Affairs, Pharmacovigilance, local and global manufacturing sites to support GQP activities for compliant and stable supply of products.

Qualification & Experience:

BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred. Must have strong knowledge of and broad experience in Quality Assurance. Must be conversant with applicable regulatory standards including pharmacopeial standards.

Must have strong GMP and Analytical knowledge. Must have strong demonstrated communication skills in Japanese and English. Some level of contractual and financial awareness is required.

Personal Qualities:

Highly motivated and engaged individual, with strong interpersonal and leadership skills. Strong strategic and continuous improvement mindset with a collaborative and problem-solving attitude.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/31/2024

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