Product Quality Director, Hybrid Modalities Leader

Amgen SA; Thousand Oaks (CA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Flexible work models

Total Rewards Plan

Retirement and Savings Plan

Medical, dental, vision coverage

Stock-based incentives

Job summary

Amgen, a leading biotech company, seeks a Product Quality Director for Hybrid Modalities to lead the Product Quality Leader (PQL) and drive technical leadership across PQ, QA, QC, and regulatory interfaces. The role spans development to commercialization, ensuring robust quality strategies for complex hybrid modalities.

The candidate will mentor PQT members, oversee stability programs, regulatory filings, and GMP compliance while collaborating with global sites and regulatory bodies to support

Qualifications

• Doctorate Degree & 4 years of Quality, Operations, Scientific, or Manufacturing experience
• Master's Degree & 7 years of Quality, Operations, Scientific, or Manufacturing experience
• Bachelor's Degree & 9 years of Quality, Operations, Scientific, or Manufacturing experience
• Advanced degree in chemistry, biochemistry, biology, or related biotech sciences
• 8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing
• 6+ years working in a regulated environment (direct GMP)
• 4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
• 2+ years experience as a technical expert or product champion
• 1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation
• 1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
• Experience in Project Management in support of product development
• Knowledge of protein and small molecule quality, compliance and regulatory requirements
• Knowledge of analytical techniques used for small molecule and protein product quality control
• Understanding of drug substance and drug product development and manufacturing
• Strong leadership and management skills
• General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
• Previous experience working on a cross-functional team in a matrix environment
• Excellent written and verbal communication skills, including facilitation and presentation skills

Responsibilities

• Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for hybrid modality programs (such as ADCs), including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
• Provide expertise in science and risk-based evaluation of complex processes and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
• Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
• Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
• Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
• Actively mentor new and existing team members to develop Product Quality core skills

Skills

Cross-functional leadership

Quality leadership

Regulatory communication

Project management

Risk assessment

Analytical thinking

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Job description

Amgen, a leading biotech company, seeks a Product Quality Director for Hybrid Modalities to lead the Product Quality Leader (PQL) and drive technical leadership across PQ, QA, QC, and regulatory interfaces. The role spans development to commercialization, ensuring robust quality strategies for complex hybrid modalities.

The candidate will mentor PQT members, oversee stability programs, regulatory filings, and GMP compliance while collaborating with global sites and regulatory bodies to support