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Job Summary

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.

Operating as the primary QA owner for clinical product complaints, this individual will collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation. The role plays a critical part in safeguarding patient safety, product quality, and regulatory compliance throughout clinical development.

Relationships: 

Reporting to the VP, Quality Assurance.

The position will interact with all areas of Clinical, Regulatory Affair, and Pharmacovigilance. In addition, clinical within Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

Externally, the position will engage with CROs and CMOs. Supporting and participating in regulatory inspections and audits, serving as the QA subject matter expert for clinical product complaint processes.

Job Responsibilities

Clinical Product Complaint Management

• 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.
• Regulatory & Inspection Support
• 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.

Physical Requirement:  Ability to travel up to 10%.

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

The base compensation range for this position is $120,300 to $222,600. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also 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. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on February 4th. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.