Associate Director, Quality Assurance, Quality Processes jobs in United States
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Vera Therapeutics, Inc. · 9 hours ago

Associate Director, Quality Assurance, Quality Processes

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Associate Director, QA Quality Processes will lead the administration and continuous improvement of Quality Processes in the electronic Quality Management System, ensuring compliance and scalability to support company growth.

BiotechnologyHealth Care
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H1B Sponsor Likelynote

Responsibilities

Collaborate with QA colleagues to define, develop, implement, and maintain Quality Processes such as Quality Events & Deviations, CAPAs, Complaints, and Change Controls
Lead or assist GxP personnel with the initiation, evaluation, investigation, implementation, and/or closure of records according to respective Quality Process
Establish GxP policies and/or procedures (e.g., SOPs, work instructions)
Support Quality Systems and Compliance processes and initiatives, such as determining and reporting of metrics as part of Quality Management Review, as appropriate
Perform other duties and responsibilities as the company may assign from time to time, including non-Quality assignments, as required

Qualification

Quality AssuranceQuality ProcessesElectronic Quality Management SystemsRegulatory inspectionsGxP knowledgeCritical analysisCommunication skillsProblem solvingDecision-making

Required

Bachelor's degree in Life Sciences, Engineering, Quality, or related discipline required
Minimum of 7 years in Quality Assurance within the pharmaceutical/biotech industry
Experience with Quality Processes including Deviations, CAPAs, Complaints, and Change Control required
Prior experience working directly within electronic Quality Management Systems (e.g., ZenQMS, Veeva)
Strong preference for experience working with ZenQMS
Proven expertise in the execution of robust investigations including robust root cause analysis and risk assessment
Strong knowledge of GxP, ICH, FDA, EMA, and global regulatory expectations
Proven ability to manage cross-functional projects in a fast paced, collaborative environment
Excellent written and verbal communication skills with a focus on clarity, compliance, and influence
Demonstrated creativity, problem solving, critical analysis, initiative, judgment and decision-making skills
Ability to operate in alignment with Vera's core values

Preferred

Advanced degree preferred
Prior experience with Regulatory inspections is preferred

Company

Vera Therapeutics, Inc.

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Vera Therapeutics, Inc.

H1B Sponsorship

Vera Therapeutics, Inc. 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
2025 (3)
2024 (2)

Funding

Current Stage
Public Company
Total Funding
$1.23B
Key Investors
Oxford Finance LLCAbingworth
2025-12-09Post Ipo Equity· $261M
2025-06-03Post Ipo Debt· $75M
2024-10-28Post Ipo Equity· $300M

Leadership Team

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David L. Johnson
Chief Operating Officer
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Kerry Cooper
Senior Vice President Medical Affairs
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Company data provided by crunchbase