Manager, GxP Compliance at Vera Therapeutics, Inc.

Brisbane, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

163000.0

Posted On

07 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Audit Management, QMS Administration, Internal Audits, Record Management, KPI Tracking, Process Improvement, Regulatory Compliance, Excel, Adobe Acrobat Professional, Electronic QMS, Data Integrity, Problem-Solving, Organizational Skills, Stakeholder Relationship Building, Issue Resolution

Industry

Biotechnology Research

Description

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. RESPONSIBILITIES: Audit Management: 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. Compliance and Continuous Improvement: 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. QUALIFICATIONS: 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. Preferred experience working with an electronic QMS such as ACE, Veeva, or Zen. 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. 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. For this role, the anticipated base pay range is $118,000—$163,000 USD 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. Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/. 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.

Responsibilities

The Manager, GxP Compliance will oversee daily GxP Compliance operations, collaborating with external providers, auditors, and internal teams to ensure adherence to regulatory requirements and quality standards. Key duties include managing audits, tracking contract service provider qualifications, administering the Quality Management System, and analyzing metrics for continuous improvement.