Manager, QA Document Control and Training

Title: Manager, QA Document Control and Training

Location: Brisbane, California

About Us:

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 fully humanized fusion protein self-administered at home as a subcutaneous 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 considering 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 Manager, QA Document Control and Training will report to the Associate Director, QA, and will be responsible for overseeing the day-to-day operations of the Document Control and Training systems. This role requires close collaboration with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards. The ideal candidate will be a proactive subject matter expert (SME) with proven experience in managing document lifecycle processes, training programs, and quality systems within a pharmaceutical or regulated environment.

RESPONSIBILITIES:

Document Control Management:

• Work closely with stakeholders to create, format, and manage controlled documents and templates within the electronic Document Management System (eDMS).
• Administer the eDMS and electronic Learning Management System (eLMS), ensuring system compliance through periodic reviews.
• Oversee the entire document lifecycle, including creation, routing, review, approval, periodic review, and archival to maintain data integrity and compliance.
• Manage paper-based records and ensure proper archiving and retrieval processes are in place.

Training Program Oversight:

• Support GxP training initiatives within the organization, acting as a Subject Matter Expert (SME) for training programs.
• Ensure training content is developed, maintained, and assigned appropriately in the eLMS.
• Support internal audits and regulatory inspections by providing training records and documentation as needed.

Compliance and Continuous Improvement:

• Track, compile, and analyze Key Performance Indicators (KPIs) and metrics related to Document Control and Training to drive continuous improvement.
• Identify and implement process improvements to enhance the efficiency and effectiveness of document and training systems.
• Ensure compliance with applicable GxP, FDA, and other regulatory requirements by maintaining an up-to-date knowledge of industry best practices.

QUALIFICATIONS:

• BA/BS degree in a related field or equivalent experience.
• 5+ years of relevant experience in a regulated environment, preferably within a QA function.
• Strong understanding of FDA, ICH, and international pharmaceutical regulations and guidelines.
• In-depth understanding of Good Documentation Practices (GDocP) and ALCOA++ principles.
• Hands-on experience administering eDMS and eLMS. Experience with Veeva is required.
• Advanced Proficiency in Microsoft Word (formatting, templates, forms, embedded hyperlinks), with basic competence in Excel and Adobe Acrobat Professional.
• Experience supporting audits and regulatory inspections with strong knowledge of data integrity and compliance best practices.
• Demonstrated ability to work independently and cross-functionally, building relationships with key stakeholders.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
• Excellent communication, problem-solving, and issue resolution skills.
• Familiarity with Data Integrity principles and continuous improvement methodologies (e.g., Lean, Six Sigma) is a plus.

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 begins at $125,000. 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.

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

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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