Senior Product Quality Leader - Biologics & Regulatory

Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 139,000 - 188,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Stock-based incentives

Flexible work models

Job summary

Amgen in Thousand Oaks, CA is recruiting a Principal Product Quality Leader to provide technical leadership across Product Quality, Regulatory, and Manufacturing teams. You will own GMP-related activities and author/review regulatory filings, with responsibility for one or more late-stage or commercial biologics programs.

You will engage with cross-functional teams on product filings, investigations, change controls, and product quality risk assessments, helping to develop, implement, and manage

Qualifications

• Doctorate or master's or bachelor's with relevant QA/Operations/manufacturing experience.
• Experience in regulated environments and biologics is preferred.
• Experience authoring or reviewing regulatory documents.

Responsibilities

• Provide cross-functional quality leadership for late phase and commercial programs.
• Develop strategies and perform risk-based evaluation of complex quality data.

Skills

Oral communication

Written communication

cGMP knowledge

Regulatory knowledge

Data management

Education

Doctorate degree / 2 years QA/Operations

Master's degree / 4 years QA/Operations

Bachelor's degree / 6 years QA/Operations

Associate's degree / 10 years QA/Operations

High School Diploma / 12 years QA/Operations

Job description

Amgen in Thousand Oaks, CA is recruiting a Principal Product Quality Leader to provide technical leadership across Product Quality, Regulatory, and Manufacturing teams. You will own GMP-related activities and author/review regulatory filings, with responsibility for one or more late-stage or commercial biologics programs.

You will engage with cross-functional teams on product filings, investigations, change controls, and product quality risk assessments, helping to develop, implement, and manage