Remote Principal Product Quality Leader, Synthetics

BioSpace; Thousand Oaks (CA); Presencial; USD 180.000 - 280.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive benefits

Flexible work models where possible

Retirement and savings plan

Stock-based long-term incentives

Time-off programs

Descripción de la vacante

Amgen is seeking a Principal Product Quality Leader (Synthetics) to provide technical expertise and leadership within the Product Quality organization. The role interfaces with Product Quality Leaders, International Quality, QC, Regulatory, Process Development, QA, and other departments on projects, investigations, and regulatory submissions related to synthetic products.

The candidate will author and review GMP/regulatory documents, manage data systems, and drive strategies to meet Product

Formación

• Doctorate or Masters with relevant QA/QC, manufacturing or regulatory experience.
• Experience coordinating with multiple Quality, Regulatory and Manufacturing functions.
• Strong knowledge of GMP and international filing expectations.

Responsabilidades

• Provide cross-functional quality leadership for late phase and commercial synthetic programs.
• Develop strategies for product quality, comparability, stability and regulatory filing sections.
• Author and review GMP/regulatory documents and manage data systems.
• Support responsible for product quality risk assessments and product health initiatives.

Conocimientos

Quality leadership

Cross-functional

cGMP knowledge

Regulatory submissions

Analytical methods

Educación

Doctorate degree

Masters degree

Bachelors degree

Associate's degree

High School Diploma

Descripción del empleo

Amgen is seeking a Principal Product Quality Leader (Synthetics) to provide technical expertise and leadership within the Product Quality organization. The role interfaces with Product Quality Leaders, International Quality, QC, Regulatory, Process Development, QA, and other departments on projects, investigations, and regulatory submissions related to synthetic products.

The candidate will author and review GMP/regulatory documents, manage data systems, and drive strategies to meet Product