**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)