QA Manager (External sites management)

Amgen

Career Category

Quality

Job Description

Description

Quality and Compliance oversight of External sites. Ensure External site activities are in alignment with applicable product CTA /Marketing Application.

Key Responsibilities

  • Serve as the main Quality point of contact related to Amgen product at External site
  • Manage External site to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements
  • Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses
  • Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site
  • Provide quality oversight of the manufacturing, testing, and release of Amgen products at External site
  • Author and drive actionable site inspection readiness plans
  • Identify and mitigate risk at the External site
  • Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews
  • Escalate risks or roadblocks to management
  • Drive continuous improvements and Amgen first mindset
  • Perform batch disposition activities in support of lot release
  • Build relationship with key Amgen stakeholders including Amgen KK.

Authority

  • Decision to release or Reject batches
  • Decision to approve or reject deviations, Change Control, CAPA
  • Decision to approve QAGR
  • Provide Quality position on GMP related topics and strategy for the site
  • Decision to approve Master batch Records/Raw Material Specifications

Basic Qualifications (Education):

Doctorate degree & 2 years of directly related experience OR

Master’s degree & 4 years of directly related experience OR

Bachelor’s degree & 5 years of directly related experience OR

Qualifications (Skill and Knowledge):

  • Demonstrated ability to manage relationship development and maintenance and negotiation skills.
  • Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers.
  • Pharmaceutical/ Biologics product commercialization and lifecycle management experience
  • Knowledge of regulatory authority inspection processes
  • Experience in Japan with multiple language capability (English, Japanese)
  • Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
  • Self leadership and motivation with high personal integrity and application of Amgen Values in daily operations.
  • Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff
  • Ability for travel to international destinations as needed
  • Leadership experience leading teams, projects, programs or directing the allocation of resources
  • Experience with Japanese pharmaceutical companies
  • Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan (preferred)
  • Experience with commercial products (preferred)
  • Experience with medical devices in Japan (preferred)

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Confirmed 6 hours ago. Posted 30+ days ago.

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