Global Product Quality Director

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Stock-based incentives

Flexible work models

Time off

Job summary

Amgen seeks a Product Quality Director to lead the Product Quality Team, providing expert scientific oversight, strategic leadership, and cross-functional collaboration across PQ, Regulatory, and manufacturing groups. The role emphasizes lifecycle management for large molecule products, risk assessment, and regulatory readiness.

The successful candidate will mentor staff, drive compliant quality systems, and partner with executive leadership to advance development and commercial products while

Qualifications

• Doctorate degree and 4 years of Quality/Operations/Scientific/Manufacturing experience, OR
• Masters degree and 7 years of Quality/Operations/Scientific/Manufacturing experience, OR
• Bachelor's degree and 9 years of Quality/Operations/Scientific/Manufacturing experience
• Advanced degree in chemistry, biochemistry, biology, or related biotechnology sciences
• Expertise in protein and small molecule analysis and industry regulations
• 8+ years of pharmaceutical experience with increasing responsibility in quality/analytical development/process development/pharmaceutics/regulatory/manufacturing
• 6+ years working in a regulated environment (GMP)
• 5+ years managing staff with increasing responsibilities and larger groups
• 2+ years experience as a PQL/technical professional
• 1+ years of experience with regulatory filing documentation
• 1+ years supporting non-conformance investigations
• Experience in Project Management for product development
• Knowledge of protein and small molecule quality and regulatory requirements
• Knowledge of analytical techniques for protein product quality control
• Understanding of drug substance/product development and manufacturing
• Strong leadership and management skills
• General knowledge of cGMP and filing regulations

Responsibilities

• Provide effective cross-functional quality leadership for late phase and commercial programs.
• Develop patient-oriented strategies accounting for business needs and complex issues.
• Communicate complex information to Amgen leadership and regulatory agencies.
• Maintain knowledge of cGMP and international regulatory expectations.
• Anticipate scientific/technical trends and their implications for Amgen.
• Mentor new and existing team members to develop Product Quality skills.

Skills

Quality leadership

Product Quality

Regulatory filings

cGMP knowledge

Stakeholder communication

Education

Doctorate degree

Master's degree

Bachelor's degree

Advanced degree in chemistry/biochemistry/biology

Job description

Amgen seeks a Product Quality Director to lead the Product Quality Team, providing expert scientific oversight, strategic leadership, and cross-functional collaboration across PQ, Regulatory, and manufacturing groups. The role emphasizes lifecycle management for large molecule products, risk assessment, and regulatory readiness.

The successful candidate will mentor staff, drive compliant quality systems, and partner with executive leadership to advance development and commercial products while