Associate Director, Quality Assurance, Quality Processes

Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and MAU868, a monoclonal antibody designed to neutralize infection with BK virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary: 

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.   

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. 

Qualifications:  

• 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. 

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