Product Quality Leader, Hybrid Modalities

Amgen Inc.

Thousand Oaks (CA)

Hybrid

USD 176,000 - 239,000

Full time

7 days ago

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Benefits offered by this job

Flexible work models

Comprehensive benefits

Job summary

Amgen is seeking a Product Quality Director for Hybrid Modalities to lead the Product Quality Team, ensure robust quality programs, and drive regulatory readiness across the PDT. You will partner with PQ, Regulatory, Process Development, and Manufacturing to deliver compliant, scalable solutions for both large and small molecule programs.

The role requires deep cGMP knowledge, strategic thinking, and strong leadership to mentor teams and influence cross-functional stakeholders in a fast-paced

Qualifications

Doctorate Degree with 4 years of related experience OR
Master's Degree with 7 years of relevant experience OR
Bachelor's Degree with 9 years of relevant experience

Responsibilities

Provide effective, cross-functional quality leadership for hybrid modality programs.
Lead the Product Quality Team and oversee stability, comparability, and regulatory filing sections.
Develop patient-focused product quality strategies aligned with business needs.
Demonstrate proficiency in cGMP and international regulatory expectations.
Mentor team members to build Product Quality core skills.
Collaborate with PQ staff, executive leadership, and regulatory bodies.

Skills

Leadership

Project management

Cross-functional collaboration

Communication skills

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Job description

The role requires deep cGMP knowledge, strategic thinking, and strong leadership to mentor teams and influence cross-functional stakeholders in a fast-paced

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