Product Quality Associate Director

Scorpion Therapeutics; United States; Hybrid; USD 150,000 - 180,000; Full time

Job summary

Amgen seeks a Product Quality Associate Director to provide technical quality oversight for late-stage or commercial biologics, ensuring strategies align with regulatory standards and support manufacturing and development programs.

Responsibilities include leading Product Quality teams, coordinating with Regulatory, QC, Process Development, and QA, and overseeing change controls, stability, and comparability assessments, as well as authoring regulatory documents.

Qualifications

• Doctorate with 3+ years or Master's with 5+ years in Quality, Operations, or related field.
• Experience with biologics and regulated environments; regulatory documentation preferred.

Responsibilities

• Lead Product Quality teams and coordinate with Regulatory, QC, Process Development, and QA.
• Oversee change controls, stability, comparability assessments and regulatory document authoring/review.

Skills

cGMP knowledge

Regulatory knowledge

Data management

Communication

Problem-solving

Education

PhD in Quality/related field

MS in Quality/related field

Job description

Role: Product Quality Associate Director, leading technical quality oversight for late-stage or commercial biologics at Amgen. Objectives: ensure product quality strategies align with regulatory standards and support manufacturing and development programs.

Responsibilities

• provide leadership within Product Quality teams, coordinate with cross-functional departments (Regulatory, QC, Process Development, QA), and oversee activities like product filings, change controls, stability, and comparability assessments.
• Serve as the Product Quality representative in delivery teams, influence quality strategies, and author/review regulatory documents.

Qualifications

• Doctorate with 3+ years or Master's with 5+ years in Quality, Operations, or related fields; experience with biologics and regulated environments; prior regulatory documentation experience preferred.

Skills

• strong scientific data management, cGMP knowledge, effective communication, and problem-solving abilities; proficient in global regulatory expectations.

High-Value: biologic products, late-stage or commercial development, regulatory filings, GMP compliance, cross-functional collaboration.

WorkSetup: not specified, but likely hybrid or onsite.