Vice President, Quality

Role Summary

The Vice President of Quality leads and evolves the Quality organization and is accountable for ensuring appropriate Quality oversight for the company. This role is responsible for developing, maintaining, and overseeing end-to-end GxP operations from early development through commercialization of Sangamo products. They will be responsible for managing and developing the Quality teams and respective functions: R&D and Clinical Quality, Quality Systems, Quality Assurance, and Manufacturing Quality. This role will partner with Research, Clinical Operations, Program Teams and CMC Project Management, Technical Development, External Manufacturing, Regulatory, Supply Chain, and our Service Providers, CROs, and CDMOs to drive compliance with global regulatory compliance requirements and company policies.

This will be a hybrid onsite role and we are considering candidates local to the San Francisco Bay Area.

Responsibilities

• Serve as accountable Quality leader and a member of the Technical Operations Leadership Team, operating at the executive level, and representing the company externally, as needed.
• Develop and execute a quality strategy that aligns with corporate objectives and focuses on fostering a culture of quality and continuous improvement.
• Lead preparation for and management of regulatory inspections (FDA, EMA, MHRA, etc.) across GMP, GCP, and GLP functions.
• Lead a team which has oversight for the following activities:
  • Generation and approval of policies, procedures, and training requirements in line with the Sangamo Quality System and activities.
  • R&D and Clinical Quality Assurance (CQA) including managing compliance from preclinical to commercialization in relation to ICH E6 GCP, Good Laboratory Practices (GLPs), Good Pharmacovigilance Practices (GPVP’s) and other related activities to deliver on Sangamo’s clinical goals and regulatory obligations.
  • Quality assurance and compliance for internal and external manufacturing related to Good Manufacturing Practices (GMP’s), including the following:
    • Release of clinical and commercial product, including use of QPs for ex‑US release.
    • Deviation and change control management.
    • Review of GMP manufacturing and QC documents.
    • Supplier quality management
    • Training curricula for GMP staff
  • Oversight of electronic systems used to support Quality activities
• Build, develop and coach the Quality team members.
• Maintain clear communication with project teams to ensure timely dissemination of information (product disposition, significant quality events including serious breaches, etc.)
• Facilitate authorship and review of CMC sections for regulatory submissions.
• Track project activities, deliverables, and completion relative to budgets and company objectives.
• Support strategic planning by timely communicating Quality deliverables, constraints, risks and options, and collaborating with Technical Development, Program Management, Clinical, Commercial, Supply Chain, and internal and external Manufacturing teams.
• Identify risks and assumptions in plans, anticipate problems, and plan for contingencies. Remove obstacles to move work forward and/or to get efforts back on track.
• This position reports to the Chief Technical Officer (CTO) with a dotted line reporting responsibility to the Chief Executive Officer CEO). The VP is required to keep the CTO, CEO, and the Executive Leadership Team (ELT) updated on any major compliance risk that could threaten Sangamo, Sangamo’s patients, or Sangamo stakeholders.

Qualifications

• Bachelor’s degree in life science or engineering field; an advanced degree is preferred.
• 15+ years related experience in the biotechnology or pharma industry, ideally for Advanced-therapy Medicinal Products (ATMPs) including gene-based and gene editing therapies. Advanced knowledge of drug development process with direct experience with gene-based and rAAV-based therapies preferred.
• 8+ years’ experience in GxP Quality role, leading people and team management. Preference given to candidates with leadership oversite experience in GCP, GMP, GLP and GPVP.
• Ability to operate at the executive level and represent the company internally and externally.
• Proven ability to effectively develop, communicate, and gain support for execution plans and strategies with a wide range of stakeholders at the executive level.
• Experience leading regulatory inspections, managing GCP audit programs and managing inspection readiness programs cross-functionally.
• Leadership and management skills to grow and manage a high performing Quality organization.
• Demonstrated skills in project management and working with vendors and contractors.
• Expert background in FDA, ISO, EMA, GMP and ICH requirements ideally for ATMPs.
• Proven experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
• Strong planning and tracking skills, able to see the big picture, well-organized, focused on results, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.

Other Qualifications

• Excellent interpersonal skills.
• Excellent written and oral communication skills.
• Ability to work in a fast paced and dynamic environment that will require outstanding organization skills, and management of several competing priorities while driving all projects forward and meeting program/project deliverables.
• Stature, gravitas, and confidence to gain credibility and respect of peers.
• Self-reliant, a good problem solver and results-oriented.
• Energetic, flexible, collaborative and proactive; a leader who can positively and productively impact initiatives.
• Ability to work in both our Brisbane, CA and Richmond, CA sites. It is anticipated that the Brisbane, CA site will be decommissioned in 2026.
• Ability to travel 10%, domestically