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Job Description: Provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints. Ensure compliance with global GMP, GCP, and pharmacovigilance requirements. 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. Interact with all areas of Clinical, Regulatory Affairs, and Pharmacovigilance. Engage with CROs and CMOs for regulatory inspections and audits. 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 coverage Dental coverage 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. Sick time policy Flexible vacation policy Parental leave policy Apply To this Job Company : Akero Therapeutics Salary : 120K223K a year .