Vice President, Quality

About the position

The Vice President, Quality at Vera Therapeutics is a senior leadership role responsible for overseeing the company's quality systems related to GxP (GMP, GLP, GCP) activities. This position involves designing and implementing quality strategies, ensuring compliance with global regulatory standards, and leading a team to support the quality assurance of therapeutic programs. The role requires strong leadership, strategic thinking, and the ability to communicate effectively across various departments to foster a culture of quality within the organization.

Responsibilities

• Build and lead a Quality department that supports GMP manufacturing, testing, and release, as well as nonclinical and clinical evaluations.
• Lead the Quality department in all GXP functional areas (GMP, GLP, GCP, GXP document control, GXP training).
• Provide mentoring and coaching for colleagues to build corporate-wide understanding of Quality policies and processes.
• Provide executive-level leadership on quality strategy and operations for leadership groups and cross-functional project teams.
• Support program teams by providing direction on interpretation and application of global quality regulations.
• Design and facilitate Management Reviews and adjudicate Quality concerns.
• Work collaboratively with GxP business partners, internally and externally.
• Ensure Quality oversight of external partners (CMDOs, CMOs, CROs, CTLs).
• Oversee GLP and GCP operations, including vendor selection and qualification.
• Ensure compliance with FDA, ICH, EMA, and industry standards.
• Collaborate with various departments to ensure GxP compliance in clinical supply manufacturing and study activities.
• Direct the review, approval, and release of investigational and commercial products.
• Perform or oversee internal and external audits, ensuring compliance with policies and regulations.
• Assist in performance of root cause analysis and risk assessments.
• Develop and implement Supplier Quality Management strategies and policies.
• Hire, train, and supervise internal Quality Assurance staff.

Requirements

• BS or higher degree in relevant technical discipline(s).
• 15+ years' experience in the biotechnology or pharmaceutical industry, including development of complex biologics and small molecules.
• Documented experience in a leadership position with relevant management experience.
• Thorough understanding of the industry regulatory environment related to Quality Systems.
• Proven record of working in a GxP compliant environment.
• Experience leading internal audits and regulatory agency interactions.
• Ability to build a highly effective team with strong cross-functional partnerships.
• Expert knowledge in at least one of GMP, GLP, or GCP.

Nice-to-haves

• Experience with gene therapy, vaccines, monoclonal/conjugated antibodies, and enzyme replacement therapies.
• Strong communication skills for difficult conversations regarding quality issues.
• Commitment to diversity and inclusion in the workplace.

Benefits

• 401(k) matching
• Dental insurance
• Health insurance
• Paid holidays
• Vision insurance