Product Quality Director, Hybrid Modalities (PQL Lead)

Amgen; Thousand Oaks (CA); Hybrid; USD 176,000 - 239,000; Full time

Benefits offered by this job

Remote and hybrid work options

Stock-based long-term incentives

Flexible benefits and retirement plans

Job summary

Amgen Inc. is seeking a Product Quality Director - Hybrid Modalities to lead the Product Quality function for complex hybrid programs.

You will oversee PQT activities, drive regulatory filings, and partner with leadership across QA, Regulatory, and manufacturing to ensure product quality and compliance. The role requires a PhD/MD/or advanced degree with 8+ years in quality/operations/scientific/manufacturing roles, including leadership and regulatory experience, within biotech or pharma

Qualifications

• Doctorate, Master’s or Bachelor’s with extensive Quality/Operations/Scientific/Manufacturing background.
• Advanced degree in biotech fields preferred with regulatory exposure.
• Experience leading cross-functional teams in pharma/biotech environments.
• Strong communication and leadership skills in GMP/regulatory contexts.
• Experience with regulatory filings or critical product documentation.

Responsibilities

• Provide cross-functional quality leadership for hybrid modality programs.
• Mentor and develop the Product Quality Team and staff.
• Oversee product quality, comparability, stability and regulatory filing sections.
• Interface with leadership, QA, Regulatory, and manufacturing teams.
• Drive process improvements and compliance with cGMP.

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Advanced degree in chemistry/biochemistry/biology

Quality, Operations, Scientific or Manufacturing experience

Leadership experience

Regulatory filing or documentation experience

Project Management

Cross-functional collaboration

Job description

Amgen Inc. is seeking a Product Quality Director - Hybrid Modalities to lead the Product Quality function for complex hybrid programs.

You will oversee PQT activities, drive regulatory filings, and partner with leadership across QA, Regulatory, and manufacturing to ensure product quality and compliance. The role requires a PhD/MD/or advanced degree with 8+ years in quality/operations/scientific/manufacturing roles, including leadership and regulatory experience, within biotech or pharma