About this role
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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.