Manager, GxP Compliance

Vera Therapeutics, Inc. • Brisbane, CA

5h • $118,000 - $163,000

About The Position

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 Manager, GxP Compliance will report to the Senior Director, GxP Compliance, and will be responsible for overseeing the day-to-day operations of GxP Compliance. This role requires collaboration with external contract service providers (CSP) as well as auditors and internal cross-functional teams to ensure compliance with regulatory requirements and quality standards. The ideal candidate will be a proactive subject matter expert (SME) with proven experience in managing and performing audits, including but not limited to assisting with tracking, scheduling, and following up on responses and CAPA.

Requirements

• BA/BS degree in a related field or equivalent experience.
• Minimum of 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.
• Advanced Proficiency 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.

Nice To Haves

• Preferred experience working with an electronic QMS such as ACE, Veeva, or Zen.
• Familiarity with Data Integrity principles and continuous improvement methodologies (e.g., Lean, Six Sigma) is a plus

Responsibilities

• Work closely with auditors and stakeholders to create agendas, coordinate audits, follow-up on responses and CAPA, and track qualification status of contract service providers.
• Administer the Compliance/Audit Quality Management System (QMS).
• Assist with internal audits and supplemental projects.
• Support audits on an as-needed basis.
• Manage paper-based records and ensure proper archiving and retrieval processes are in place.
• Track, compile, and analyze Key Performance Indicators (KPIs) and metrics related to Auditing 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level