Vera Therapeutics
Vice President, Quality
Vera Therapeutics, Brisbane, California, United States, 94005
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.
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.
Responsibilities:
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).
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.
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.
Ensure Vera’s practices are compliant with FDA, ICH, EMA, and industry standards.
Collaborate 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.
Collaborate to ensure resolution of complex supplier, partner, vendor performance issues.
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.
Develop and implement Supplier Quality Management strategies and policies.
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 in biotechnology or pharmaceutical industry.
Documented experience in leadership position with relevant management experience required.
Thorough understanding of industry regulatory environment related to Quality Systems.
Proven record of working in a GxP compliant environment.
Direct experience in leading internal audits and regulatory agency interactions.
Building a highly effective team with strong cross-functional partnerships.
Effective ‘voice’ for Quality in cross-functional program teams.
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.
Vera Therapeutics Inc. is an equal-opportunity employer.
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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.
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.
Responsibilities:
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).
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.
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.
Ensure Vera’s practices are compliant with FDA, ICH, EMA, and industry standards.
Collaborate 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.
Collaborate to ensure resolution of complex supplier, partner, vendor performance issues.
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.
Develop and implement Supplier Quality Management strategies and policies.
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 in biotechnology or pharmaceutical industry.
Documented experience in leadership position with relevant management experience required.
Thorough understanding of industry regulatory environment related to Quality Systems.
Proven record of working in a GxP compliant environment.
Direct experience in leading internal audits and regulatory agency interactions.
Building a highly effective team with strong cross-functional partnerships.
Effective ‘voice’ for Quality in cross-functional program teams.
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.
Vera Therapeutics Inc. is an equal-opportunity employer.
#J-18808-Ljbffr