Sangamo Therapeutics, Inc.
Vice President, Quality
Sangamo Therapeutics, Inc., Brisbane, California, United States, 94005
Overview
Vice President, Quality at Sangamo Therapeutics, Inc. Location: Brisbane, CA. This is a hybrid onsite role and local candidates to the San Francisco Bay Area are being considered. 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 with 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, GLPs, GPVPs 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 GMPs, including: 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. Education, Experience And Skills
Bachelor’s degree in life science or engineering; an advanced degree is preferred. 15+ years of 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 the drug development process with direct experience in gene-based and rAAV-based therapies preferred. 8+ years’ experience in a GxP Quality role, leading people and team management; leadership oversight in GCP, GMP, GLP and GPVP preferred. Ability to operate at the executive level and represent the company internally and externally. Proven ability to 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 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 and regulatory inspections. Strong planning and tracking skills, organized, results-focused, able to manage multiple projects with effective time management. Excellent judgment and creative problem-solving, including negotiation and conflict resolution skills. Other Qualifications
Excellent interpersonal, written, and oral communication skills. Ability to work in a fast-paced, dynamic environment with outstanding organization and the ability to manage several competing priorities while driving deliverables. Stature, gravitas, and confidence to gain credibility and respect among peers. Self-reliant, a good problem solver and results-oriented. Energetic, flexible, collaborative and proactive; a leader who can positively impact initiatives. Ability to work at Brisbane, CA and Richmond, CA sites, with Brisbane site anticipated to be decommissioned in 2026. Travel up to 10% domestically. Equal Opportunity
Sangamo is an equal opportunity employer. We value diversity, inclusion, and belonging in the recruitment and hiring process. All qualified applicants will receive consideration without regard to race, color, sex, gender identity, sexual orientation, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, or any other basis protected by law. Pay and Application Notes
The anticipated salary range applies to candidates working in the San Francisco Bay Area. Final salary is based on factors including experience, education, and industry norms. This salary range may not apply to remote positions. Note to External Recruiters
We do not accept unsolicited resumes from sources other than candidates themselves. If you wish to be considered for the presentation of candidates, please email recruiting@sangamo.com. We will reach out if there is a business need for your services.
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Vice President, Quality at Sangamo Therapeutics, Inc. Location: Brisbane, CA. This is a hybrid onsite role and local candidates to the San Francisco Bay Area are being considered. 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 with 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, GLPs, GPVPs 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 GMPs, including: 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. Education, Experience And Skills
Bachelor’s degree in life science or engineering; an advanced degree is preferred. 15+ years of 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 the drug development process with direct experience in gene-based and rAAV-based therapies preferred. 8+ years’ experience in a GxP Quality role, leading people and team management; leadership oversight in GCP, GMP, GLP and GPVP preferred. Ability to operate at the executive level and represent the company internally and externally. Proven ability to 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 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 and regulatory inspections. Strong planning and tracking skills, organized, results-focused, able to manage multiple projects with effective time management. Excellent judgment and creative problem-solving, including negotiation and conflict resolution skills. Other Qualifications
Excellent interpersonal, written, and oral communication skills. Ability to work in a fast-paced, dynamic environment with outstanding organization and the ability to manage several competing priorities while driving deliverables. Stature, gravitas, and confidence to gain credibility and respect among peers. Self-reliant, a good problem solver and results-oriented. Energetic, flexible, collaborative and proactive; a leader who can positively impact initiatives. Ability to work at Brisbane, CA and Richmond, CA sites, with Brisbane site anticipated to be decommissioned in 2026. Travel up to 10% domestically. Equal Opportunity
Sangamo is an equal opportunity employer. We value diversity, inclusion, and belonging in the recruitment and hiring process. All qualified applicants will receive consideration without regard to race, color, sex, gender identity, sexual orientation, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, or any other basis protected by law. Pay and Application Notes
The anticipated salary range applies to candidates working in the San Francisco Bay Area. Final salary is based on factors including experience, education, and industry norms. This salary range may not apply to remote positions. Note to External Recruiters
We do not accept unsolicited resumes from sources other than candidates themselves. If you wish to be considered for the presentation of candidates, please email recruiting@sangamo.com. We will reach out if there is a business need for your services.
#J-18808-Ljbffr