Job Summary

The Associate Director of GCP Quality Assurance will provide quality oversight and compliance support for Clinical Development and Pharmacovigilance (PV) activities related to biologic development clinical programs. This individual will be responsible for ensuring that clinical trial execution, safety reporting, and pharmacovigilance systems meet Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) requirements, as well as all applicable global regulatory standards. This individual will partner closely with Clinical, Pharmacovigilance, Regulatory Affairs, and external service providers to ensure oversight of clinical programs and safety activities that safeguard patient rights, safety, and data integrity.

Relationships: 

Reporting to the VP, Quality Assurance.

The position will interact with all areas of Clinical and Regulatory Affair. 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.  For CROs it will be in support of Audits.

Job Responsibilities

• Clinical Operations Oversight
  • Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs.
  • Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements.
  • Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams.
  • Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations.
• Quality Systems & Compliance
  • Review and manage deviations, CAPAs, and change controls associated with Clinical activities.
  • Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations.
  • Support continuous improvement initiatives across Clinical QA functions.
  • Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates.
• Cross-Functional & External Collaboration
  • Serve as a QA liaison between Clinical Operations, Regulatory Affairs, and external partners (CROs, Safety Vendors).
  • Support training and awareness of GCP and corporate quality policies across internal teams and contractors.
  • Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

Physical Requirement:  Ability to travel up to 25%.

Qualifications

• Bachelor's degree with 9+ years of experience required OR
  • Master's degree and 7+ years of experience 
  • PhD/JD and 5+ years of experience
  • MD/DO and 1+ years of experience may be considered 
• Relevant experience in Quality Assurance within Clinical Operations, preferably in biologics or biotechnology.
• Strong knowledge of global regulatory requirements: ICH-GCP, EU GCP Directive/Regulation, FDA GCP regulations, and international GVP standards.
• Experience with CRO vendor oversight, including audits and inspections.
• Familiarity with electronic systems for clinical data (e.g., EDC, CTMS, Argus, ARISg, Veeva Vault).
• Demonstrated success in managing quality issues, audits, and regulatory inspections.
• Excellent communication, organizational, and interpersonal skills with the ability to influence and collaborate across functions and geographies

The base compensation range for this position is $152,700 to $267,300. 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.