Akero Therapeutics · 1 day ago
Associate Director of Quality Assurance – GCP and Pharmacovigilance
United States
Full-time
Remote
Lead/Staff, Director/Executive
$165K/yr - $175K/yr
10+ years expAkero Therapeutics is a clinical stage biopharmaceutical company focused on developing treatments for patients with serious metabolic diseases. The Quality Assurance Representative will oversee compliance for Clinical Development and Pharmacovigilance activities, ensuring adherence to regulatory standards and high-quality execution of clinical trials.
BiotechnologyLife ScienceTherapeutics
Responsibilities
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
Provide QA support for global PV activities, including adverse event (AE) reporting, signal detection, and safety data exchange agreements
Monitor compliance with global GVP requirements, including FDA, EMA, MHRA, Health Canada, and other health authorities
Support audits and inspections of PV systems and processes, including preparation, participation, and follow-up on corrective/preventive actions (CAPAs)
Review and manage deviations, CAPAs, and change controls associated with Clinical and PV activities
Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations
Support continuous improvement initiatives across Clinical QA and PV QA functions
Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates
Serve as a QA liaison between Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external partners (CROs, Safety Vendors)
Support training and awareness of GCP, GVP, and corporate quality policies across internal teams and contractors
Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections
Qualification
Required
Bachelor's or advanced degree in Life Sciences, Biotechnology, Pharmacy, or related field
Minimum of 10 years of experience in Quality Assurance within Clinical Operations and/or Pharmacovigilance, 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 and PV vendor oversight, including audits and inspections
Familiarity with electronic systems for clinical and safety 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
Company
Akero Therapeutics
Akero Therapeutics is a biotechnology company focused on reversing the NASH epidemic by restoring the body’s metabolism to a balanced state.
11-50 employees
H1B Sponsorship
Akero Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$951.1MKey Investors
Pfizer Breakthrough Growth InitiativeHercules CapitalJanus Henderson Investors
2025-10-09Acquired
2024-03-05Post Ipo Equity· $366.9M
2023-05-15Post Ipo Equity· $124.2M
Leadership Team
P
Patrick Lamy
SVP, Commercial Strategy
Scott Gangloff
Chief Technical Officer
Recent News
2026-01-03
2025-12-17
Genetic Engineering News
2025-12-16
Company data provided by crunchbase