Vice President, Quality

vor 4 Wochen

Brisbane, Österreich Tideri Jobbörse Vollzeit

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).
Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus.
For more information, please visit:
www.veratx.com .
Our values are the cornerstone of our culture, guiding everything we do—from hiring great people to advancing our mission together.
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 role requires experience, knowledge, and leadership credibility to ensure compliance with Quality standards and corporate-wide commitment to Quality principles.
Responsibilities:
Build and lead a Quality department that supports GMP manufacturing, testing, and release, as well as nonclinical and clinical evaluations of Vera's therapeutic programs.
Lead the Quality department in all GXP functional areas as Vera continues clinical development and launch readiness.
Provide mentoring and coaching for colleagues to build understanding of Quality policies and processes.
Provide executive-level leadership on quality strategy & operations for leadership groups and project teams.
Support program teams with direction on interpretation and application of global quality regulations.
Design and facilitate Management Review and adjudicate Quality concerns.
Work collaboratively with GxP business partners, internally and externally.
Ensure Quality oversight of Vera's selected external partners.
Oversee GLP and GCP operations internally or at partners.
Ensure compliance with FDA, ICH, EMA, and industry standards.
Collaborate with various departments to ensure GxP compliance.
Direct the review, approval, and release of all Vera investigational and commercial products.
Perform or oversee internal and external audits and review audit reports and CAPAs.
Resolve complex supplier and partner performance issues.
Assist or lead in performance of root cause analysis and risk assessments.
Oversee technical data and documentation review for compliance.
Develop and implement Supplier Quality Management strategies.
Hire, train, and supervise internal Quality Assurance staff and/or consultants.
Qualifications:
BS or higher degree in relevant technical discipline(s) required.
15+ years' experience within biotechnology or pharmaceutical industry.
Documented experience in a leadership position with relevant management experience.
Thorough understanding of industry regulatory environment related to Quality Systems.
Proven record of working in a GxP compliant environment.
Direct experience leading internal audits and regulatory agency interactions.
Ability to build a highly effective team with strong cross-functional partnerships.
Expert knowledge in GMP, GLP or GCP.
A genuine commitment to Patients First.
Tenacity to solve complex problems.
Able to embrace diversity and inclusion.
Vera Therapeutics Inc. is an equal-opportunity employer.
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