Manager of Quality Assurance Product Complaints

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing treatments for serious metabolic diseases. The Manager of Quality Assurance Product Complaints will oversee the intake, investigation, and management of clinical-stage combination product complaints, ensuring compliance with global regulations and safeguarding patient safety and product quality.

Responsibilities:

• Serve as QA owner for clinical-stage combination product complaints, including receipt, triage, documentation, investigation, and closure
• Ensure timely assessment of complaints for potential impact to patient safety, product quality, and regulatory reporting requirements.Review and approve complaint records, investigation reports, and final dispositions in alignment with corporate quality standards and global regulations
• Maintain current knowledge of global complaint handling and quality regulations (FDA, EMA, MHRA, Health Canada, PMDA, ICH, PIC/S, WHO)
• Partner with Regulatory Affairs and Pharmacovigilance to support complaint-related regulatory submissions and reporting, including INDs, BLAs/MAAs, and safety reports where applicable
• Support and participate in regulatory inspections and audits, serving as the QA subject matter expert for clinical product complaint processes
• Prepare and review responses to regulatory questions, findings, and commitments related to product complaints

Requirements:

• Bachelor's degree and 7+ years of experience OR: Master's degree and 4+ years of experience OR: 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
• Experience with electronic quality systems (e.g., Veeva) and strong proficiency in data integrity standards