Senior Manager Quality Compliance

Role Description :

The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgen's Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC). This role will shape, coordinate and provide input in the development of policy, regulatory requirements, and expectations consistent with Amgen's position and priorities on GMP / GDP primarily in JAPAC and regarding related international organizations (e.g., APEC, ICH, Pharmacopoeias, PIC / S, WHO) in support for GCP, GLP, GPvP compliance, as requested. The senior manager will explain global regulatory and GxP compliance requirements incl. supply chain and trade, focus on regulations and guidance on GMP / GDP / GSP in JAPAC.

Roles & Responsibilities :

• Business Improvement

External :

External and / or Internal :

Internal :

Benchmark and share regulatory, quality and GxP intelligence / inspection trends to enable alignment of our internal processes, procedures, and aspirations with global regulatory expectations throughout the product-life cycle (incl. early-warning signals)

Interface with the Amgen organization, sites, and leadership to update and alert regulatory and inspection requirements and trends, focus GMP / GDP.

Basic Qualifications and Experience :

Functional Skills : Must-Have Skills :

Good-to-Have Skills :

Soft Skills : Autonomy

Be guided by operational and project objectives

Working With Others

Personal development

Communication

Business

Skills Required

Gxp, Gmp