Vice President, Quality

Title: Vice President, Quality

Location: Brisbane, CA

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:

Reporting into the Senior Vice President, Regulatory and Quality, the Vice President, Quality will be responsible for the overall quality systems of the company’s GxP (GMP, GLP, GCP) activities. This critical hire will design, prioritize, implement, monitor, and communicate Vera’s GxP quality strategy and quality programs. As part of the development leadership team, you will establish and translate Vera’s quality strategy into operational policies, processes, procedures, and training to meet global regulatory, medical/health, and legislative standards. This role requires experience, knowledge, and leadership credibility to be effective across Vera in multiple capacities, thereby ensuring compliance with Quality standards and corporate-wide commitment to Quality principles. In addition, this role will lead the implementation of technology solutions to increase efficiency.

Responsibilities:

• In this highly visible, prominent role, the successful candidate will build and lead a Quality department that supports GMP manufacturing, testing, release, as well as nonclinical and clinical evaluations of Vera’s therapeutic programs.
• Lead the Quality department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training) as Vera continues clinical development and continues launch readiness.
• Provide mentoring and coaching for colleagues across Vera to build corporate-wide understanding of and commitment to Quality policies, processes, procedures, and applications.
• Provide executive-level leadership on quality strategy & operations for leadership groups and cross-functional project teams.
• Support program team through providing direction on interpretation and application of global quality regulations and guidance documents.
• Design and facilitate the Management Review and adjudicate Quality concerns that result in acceptable options weighing compliance risk against business objectives.
• Work collaboratively with GxP business partners, internally and externally.
• Ensure Quality oversight of Vera’s selected external partners (CMDOs, CMOs, CROs, CTLs, etc.).
• Oversee GLP and GCP operations internally or at CROs/partners, including vendor selection and qualification, study setup, protocol development, study conduct, study conclusion reporting.
• Ensure Vera’s practices are compliant with FDA, ICH, EMA, and industry standards.
• Collaborate and establish/maintain procedures in collaboration with CMC Operations, Clinical Development, Clinical Operations, Regulatory Affairs, Nonclinical Development to ensure the clinical supply manufacturing activities, nonclinical/clinical study activities are conducted in GxP compliance regulations, guidelines, and practices.
• Direct the review, approval, and release of all Vera investigational and commercial products.
• Perform or oversee internal and external audits ensuring compliance with company policies, procedures, and applicable regulations; review and approve audit reports and Corrective and Preventive Actions (CAPAs).
• Collaborate to ensure resolution of resolve complex supplier, partner, vendor performance issues.
• As appropriate, assist or lead in performance of root cause analysis, risk assessments, and identify appropriate corrective action plans.
• Oversee technical data and documentation review, to ensure compliance with FDA or relevant Health Authority regulations and internal directives, policies, and procedures.
• Develop and implement Supplier Quality Management strategies and policies to streamline processes and effectively utilize resources.
• Hire, train, and supervise internal Quality Assurance staff and/or consultants, as appropriate.

Qualifications:

• BS or higher degree in relevant technical discipline(s) required.
• 15+ years’ experience with a track record of achievements within biotechnology or pharmaceutical industry; including in development of complex biologics (such as, gene therapy, vaccines, monoclonal/conjugated antibodies, enzyme replacement therapies), and small molecules.
• Documented experience in leadership position with relevant management experience required.
• Thorough understanding of industry regulatory environment related to Quality Systems; ability to evaluate complex situations and to provide practical perspectives for evaluating regulatory, financial, or legal risks and mitigations especially where compliance guidelines are inadequate.
• Candidate must have a proven record of working in a GxP compliant environment, with demonstrated ability to lead GxP operations.
• Candidate must also have direct experience:
  • Leading internal audits and regulatory agency interactions.
  • Building a highly effective team with strong cross-functional partnerships.
  • Being an effective ‘voice’ for Quality in cross-functional program teams.
  • Be highly effective in having difficult conversations on a routine basis internally or externally with partners; must be able to preserve the relationship while confronting quality issues that create unacceptable risks for Vera.
  • Expert knowledge from extensive hands-on experience in at least one of: GMP, GLP or GCP.
  • A genuine commitment to Patients First, knowing that Quality is more than just compliance.
  • Tenacity to solve difficult, complex problems where Quality is one of several factors.
  • Able to embrace diversity and inclusion, meaning being open to other voices and approaches to Quality; willing to learn and innovate with others.

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 $307,000 - $355,000. 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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