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Role Description

The Manager of Quality Assurance Product Complaints will provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints within a fully “virtual company” operating model. This role ensures that product complaints related to clinical drug substance and drug product are handled in compliance with global GMP, GCP, and pharmacovigilance requirements.

• Operate as the primary QA owner for clinical product complaints.
• Collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation.
• Safeguard patient safety, product quality, and regulatory compliance throughout clinical development.

Qualifications

• Bachelor's degree and 7+ years of experience OR:
• Master's degree and 4+ years of experience
• PhD and 2+ years of experience may be considered
• Hands-on experience with product complaints and investigations required
• Strong understanding of cGMP, GCP, and global regulatory requirements related to clinical product complaint handling.
• Proven experience managing complaint investigations, root cause analysis, CAPA development, and trending for clinical-stage products.
• Demonstrated success supporting regulatory inspections and audits involving complaint systems and quality investigations.
• Strong interpersonal and communication skills with the ability to influence cross-functional and external partners.
• Experience with electronic quality management systems (e.g., Veeva) and deep understanding of data integrity standards.

Requirements

• Ability to travel up to 10%.

Benefits

• Base compensation range for this position is $120,300 to $222,600.
• Eligible for a company bonus based on individual and company performance.
• Long-term incentive compensation depending on the position's level or other company factors.
• Eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy.

Company Description

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need.