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About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a South San Francisco and Seattle-based clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. Sonoma Bio has initiated two Phase 1 studies to evaluate the safety and proof-of-mechanism of the company’s lead Treg cell therapy candidate, SBT-77-7101, in patients with rheumatoid arthritis and hidradenitis suppurativa. The company has a partnership with Regeneron to discover, develop and commercialize novel regulatory T cell therapies. More information at www.sonomabio.com.

Job Purpose/Summary:

Reporting to the Chief Legal Officer, the VP, Quality is instrumental in establishing and maintaining a culture of quality across Sonoma Biotherapeutics. This role is responsible for all aspects of the Quality organization, including quality oversight and compliance activities required for internal and external operations. This role will work with stakeholders across the organization, such as manufacturing, process and analytical development, regulatory, clinical development and clinical and patient operations, to implement quality and compliance systems and processes and to develop a best-in-class and scalable quality organization that is fit-for-purpose for Sonoma Bio’s phase of development.

Roles and responsibilities:

The responsibilities of the VP, Quality, are to build, lead and coach Sonoma's quality function and to build, implement and oversee Sonoma Bio’s quality systems and oversight responsibilities. This individual is responsible for building out and overseeing the day-to-day Quality operations for Quality Assurance, Quality Control, Quality Management Systems, and Compliance and Document Control. Responsibilities include implementation and continuous improvement of policies, procedures, and standards necessary to ensure compliance with applicable GXPs. Additional responsibilities include strategic planning, team building, career development, managing annual budgets and establishing annual goals and longer-term strategic plans for the Quality organization.

The VP, Quality will be responsible for the following activities:

• Foster a work culture grounded in transparency, credibility and trust and fully committed to data integrity, patient safety and compliance
• Build the Quality organization, including all Quality functions required to support the business at its current stage of development
• Develop and maintain phase-appropriate quality management systems (QMS) that are effective, appropriate and right-sized for the organization. The QMS should support release and disposition of Sonoma Bio products for use in clinical research, including procedures for document control, deviation management, corrective and preventive actions (CAPAs), and continuous improvement.
• Ensure compliance with GXP and applicable global regulations that support supply chain management, external GMP manufacturing partners, clinical trials execution and reporting, and management of GXP external vendors (eg CDMOs, CROs, contract test laboratories, investigator sites and other vendor services)
• Assure established processes and procedures safeguard the rights, safety, and well-being of clinical trial participants, as well as ensuring the integrity and reliability of clinical trial data
• Develop a culture of continuous improvement of quality systems, processes, and procedures to enhance the overall quality and compliance of clinical trial conduct, including conducting root cause analyses of compliance issues and implementing CAPAs to prevent recurrence
• Implement a risk-based audit program throughout the vendor network to assure compliant Quality management practices and procedures are practiced at external manufacturing, testing and clinical sites
• Lead the review of quality attributes and systems required to support external manufacturing
• Provide education and training to staff to support the effectiveness of Sonoma Bio compliance programs and to meet compliance standards
• Establish and manage project-specific and departmental annual operating budgets and annual departmental goals

Qualifications and Education Requirements:

• 12+ years in a Quality leadership role in the pharmaceutical or biotech Industry; additional years in QA strongly desired
• Cell therapy industry experience is required
• A Bachelor of Science degree in a scientific field required; a masters or PhD in a scientific field preferred
• Demonstrated experience in building and leading a Quality function is required
• Ability to influence peers and colleagues and gain their cooperation in placing patient safety, compliant procedures and transparency as the company’s top priority
• Capable of operating with a high-level of autonomy and willing to get directly involved in operational details as required
• Strong management and organizational skills; ability to prioritize and manage complex processes/projects
• Extensive knowledge of FDA regulatory requirements applicable to cell therapies required; knowledge of EMA and UK regulations applicable to cell therapies preferred
• Ability to apply GXP regulations and other FDA and international guidelines to all aspects of the company’s regulated operations, including GCP, CLP and GMP
• Ability to read, analyze and interpret scientific, professional and technical journals, and governmental regulations and guidance documents
• Ability to deal with abstract and concrete variables in situations where potentially limited standardization exists
• Ability to think strategically and engage in enterprise-wide thinking
• Ability to listen and ask the right questions
• Possesses confidence and is comfortable making difficult decisions
• Excellent troubleshooting skills and ability to solve complex issues
• Strong interpersonal and communication skills (verbal and written)
• Proven coaching and mentoring skills with emphasis on people development
• Ability to function in a rapidly changing environment, prioritize multiple tasks, work under timeline pressures, and drive tasks to completion

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Equal Employment Opportunity

At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees.

Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other

characteristics protected under applicable federal, state and local laws.

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply. Please submit your resume along with a cover letter to careers@sonomabio.com - resumes may also be submitted without

applying for a specific job.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us at careers@sonomabio.com