Executive Director, Clinical Quality Assurance

Title: Executive Director, Clinical Quality Assurance

Location: Brisbane, California

About Us:

Vera Therapeutics (Nasdaq: VERA), is a late-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 fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing 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 Executive Director, Clinical Quality Assurance, will report to the VP of Quality Assurance and will be responsible for the development, implementation, maintenance and oversight of Clinical Quality Assurance systems and activities supporting Good Clinical Practices (GCPs). The Executive Director is responsible for implementing strategies and tactics to promote and maintain GCP compliance, and to lead overall Inspection Readiness for Vera.

Responsibilities:

• Provides overall strategy, direction and execution for the Clinical QA function.
• Provides Clinical QA (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams.
• Ensures the implementation and maintenance of GCP compliance procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize products.
• Manages direct reports and consultants, as applicable, in the pursuit of QA objectives.
• Supports the generation and review of regulatory submissions (e.g., IND, BLA).
• Develops the overall plan and execution strategy for FDA Pre-Licensing Inspection readiness for Clinical supporting functions.
• Proactively provides GCP QA support to and collaborates with Clinical focused teams and other departments based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices.
• In collaboration with internal stakeholders, ensures risk-based quality management is applied as appropriate to Clinical studies.
• Assesses and implements applicable process and procedural updates to comply with ICHE6(R3).
• Plans, conducts, and/or assists in internal and external service provider and Clinical site audits. Reviews audit reports, and any corresponding corrective and preventative actions for adequacy.
• Partners with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary.
• Other related duties as assigned.

Qualifications:

• Bachelor's degree in life sciences or related field with a minimum of fifteen (15) years progressive experience in a Health Authority regulated Pharmaceutical/Biotechnology industry.
• Extensive understanding and knowledge of GCP and GVP US regulations, industry standards, concepts and other Health Authority standards and guidances as they relate to Quality Systems and Quality Assurance.
• Experience with Health Authority filings.
• Experience with Health Authority Inspection preparedness and conduct.
• Experience with planning and conducting GCP focused audits preferred.
• Proficient in Veeva QualityDocs and Veeva QMS.
• Demonstrates proven track record of leadership, communication, and motivation skills with internal and external Vendors.
• A strong team player with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations, and business needs.
• Provide solutions to issues. Solutions are imaginative, thorough, pragmatic, risk-based, and consistent with organization objectives.
• Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities.
• Communicate decisions and recommendations with clear justification and rationale.
• Must be able to interpret and apply GCP regulations and guidances, including 21CFR part 11 requirements.
• Maintains professional expertise and knowledge of local and international regulations related to Quality and GCP.
• Excellent written and oral communication and presentation skills.
• Ability to prioritize and multi-task successfully in a fast-paced environment.
• Excellent organizational skills and attention to detail are essential.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $230,000 - $260,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

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Fraud Alert

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Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.