QA Manager (External sites management)

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)