Associate Director, Quality Assurance, Quality Processes

Vera Therapeutics, Inc. • Brisbane, CA

7h • $160,000 - $220,000

About The Position

The Associate Director, QA Quality Processes will lead the administration, continuous improvement, and lifecycle management of Quality Processes including Quality Events & Deviations, CAPAs, Complaints, and Change Controls in our electronic Quality Management System (eQMS). This role is pivotal in ensuring that Vera’s quality systems are compliant, inspection-ready, and scalable to support company growth.

Reporting directly to the Sr. Director of Quality Systems and Compliance, the AD, QA - Quality Processes will partner cross-functionally with QA, Clinical, CMC, Regulatory, IT, and other groups to ensure quality processes are documented and processed according to Vera procedures and effectively captured in the eQMS.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality, or related discipline required. Advanced degree preferred.
• 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.
• Prior experience with Regulatory inspections is preferred.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees