Manager of Quality Assurance Product Complaints

Akero Therapeutics, a Novo Nordisk company, is seeking a Manager of Quality Assurance Product Complaints to provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints within a fully virtual company operating model.

Requirements

• 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
• Experience with electronic quality systems (e.g., Veeva) and strong proficiency in data integrity standards

Benefits

• Medical, dental and vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• 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, flex-able vacation policy, and parental leave policy