Sonoma BioTherapeutics
Sr Manager, Quality Systems
Sonoma BioTherapeutics, Seattle, Washington, us, 98127
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/SummaryReporting to the VP of Quality, the Sr Manager of QMS provides oversight and direction to all aspects of the development, implementation, and performance of the Quality Management System and any associated projects and activities. The Sr Manager of QMS works closely with functions across the business to build and maintain the systems and processes required to enable an ever evolving and phase appropriate QMS.Roles and ResponsibilitiesOwn all aspects of the Quality Management System (QMS) (e.g., training administration, document control, validation, computer systems, deviations, investigations, complaints, CAPAs, change control, audit program, supplier management program, and associated governance).Collaborate with leadership to establish near- and long-term strategic plans and objectives related to the QMS.Support decision making on implementation to ensure alignment with strategic plans, operational effectiveness, and effectively communicate throughout implementation activities.Help author and implement companywide policies, practices, and procedures.Contribute to new technology introduction (e.g., Zen QMS, Lab Guru updates, selection and implementation of new GxP software systems, etc.).Develop new methods and solve complex company-wide matters.Lead activities of the functional areas and services related to the QMS; have overall responsibility for the successful operation of assigned areas.Influence and lead cross-functionally without authority.Oversee CMC life cycles related to the QMS.Manage multiple vendors/contracts, including contract negotiation, oversight, and approvals.Present technical and business concepts to leadership, vendors, and external professionals.Display enhanced business capabilities (e.g., project management, resource and capacity planning, tactful communication, internal and external relationship management, budget responsibilities, may contribute to and or oversee capital projects, etc.).Establish and monitor QMS metrics, reporting, and cross-functional review forums as appropriate.Contribute to Annual Product Review (APR) regulatory filings.Ensure quality programs continue to evolve to support changing business objectives and goals.Define phase-appropriate strategic Quality initiatives and or improvements and drive the organizational change lifecycle.Foster a culture of continuous improvement.Provide general Quality Operations support as appropriate.Qualifications and Education RequirementsBS, MS, MBA degree and 8+ years’ experience managing Quality activities within a cGMP environment in the Biopharmaceutical industry, or a PhD and 5+ years’ experience.Comprehensive knowledge of QMS compliance requirements.GMP compliance expertise including knowledge of 21CFR210, 211, 820, ISO 9001, 13485, EU Guidelines, and FDA Guidance on Aseptic Processing.Understanding of industry standards and best practices for computer system validation, such as GAMP, FDA 21 CFR Part 11 compliance.Knowledgeable in FDA regulations and GxP systems.Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing.Advanced knowledge and experience with GxP QMS, manufacturing, Quality, and compliance.Experience enabling inspection readiness through oversight of QMS system content.Prior people leadership experience is helpful but not required.Competencies Needed:Excellent written and verbal communication skills, as applied in a dynamic technical environment.Demonstrated ability to act as an individual contributor capable of defining and driving work independently, while exercising strong judgement and decision-making.Ability to anticipate operational constraints/issues and proactively take or recommend solutions.Ability to build and maintain strong relationships, influence, and work well with others in a proactive and constructive manner.Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives.Demonstrated leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.Ability and desire to effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (Zoom/Microsoft Teams) environments.Working Conditions:This role is hybrid, part time on-site at our Seattle office.On-site work is performed in a typical office environment with standard office equipment available and used.Occasional business travel may be required.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 OpportunityAt 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 .
#J-18808-Ljbffr
www.sonomabio.com .Job Purpose/SummaryReporting to the VP of Quality, the Sr Manager of QMS provides oversight and direction to all aspects of the development, implementation, and performance of the Quality Management System and any associated projects and activities. The Sr Manager of QMS works closely with functions across the business to build and maintain the systems and processes required to enable an ever evolving and phase appropriate QMS.Roles and ResponsibilitiesOwn all aspects of the Quality Management System (QMS) (e.g., training administration, document control, validation, computer systems, deviations, investigations, complaints, CAPAs, change control, audit program, supplier management program, and associated governance).Collaborate with leadership to establish near- and long-term strategic plans and objectives related to the QMS.Support decision making on implementation to ensure alignment with strategic plans, operational effectiveness, and effectively communicate throughout implementation activities.Help author and implement companywide policies, practices, and procedures.Contribute to new technology introduction (e.g., Zen QMS, Lab Guru updates, selection and implementation of new GxP software systems, etc.).Develop new methods and solve complex company-wide matters.Lead activities of the functional areas and services related to the QMS; have overall responsibility for the successful operation of assigned areas.Influence and lead cross-functionally without authority.Oversee CMC life cycles related to the QMS.Manage multiple vendors/contracts, including contract negotiation, oversight, and approvals.Present technical and business concepts to leadership, vendors, and external professionals.Display enhanced business capabilities (e.g., project management, resource and capacity planning, tactful communication, internal and external relationship management, budget responsibilities, may contribute to and or oversee capital projects, etc.).Establish and monitor QMS metrics, reporting, and cross-functional review forums as appropriate.Contribute to Annual Product Review (APR) regulatory filings.Ensure quality programs continue to evolve to support changing business objectives and goals.Define phase-appropriate strategic Quality initiatives and or improvements and drive the organizational change lifecycle.Foster a culture of continuous improvement.Provide general Quality Operations support as appropriate.Qualifications and Education RequirementsBS, MS, MBA degree and 8+ years’ experience managing Quality activities within a cGMP environment in the Biopharmaceutical industry, or a PhD and 5+ years’ experience.Comprehensive knowledge of QMS compliance requirements.GMP compliance expertise including knowledge of 21CFR210, 211, 820, ISO 9001, 13485, EU Guidelines, and FDA Guidance on Aseptic Processing.Understanding of industry standards and best practices for computer system validation, such as GAMP, FDA 21 CFR Part 11 compliance.Knowledgeable in FDA regulations and GxP systems.Demonstrated knowledge of the application of cGMPs applicable to biologics and cell therapy manufacturing.Advanced knowledge and experience with GxP QMS, manufacturing, Quality, and compliance.Experience enabling inspection readiness through oversight of QMS system content.Prior people leadership experience is helpful but not required.Competencies Needed:Excellent written and verbal communication skills, as applied in a dynamic technical environment.Demonstrated ability to act as an individual contributor capable of defining and driving work independently, while exercising strong judgement and decision-making.Ability to anticipate operational constraints/issues and proactively take or recommend solutions.Ability to build and maintain strong relationships, influence, and work well with others in a proactive and constructive manner.Demonstrated ability to work in an organization with a range of technically, culturally, and geographically diverse teams, to influence areas not under direct control to achieve disposition objectives.Demonstrated leadership capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results that meet high-quality requirements with tight deadlines.Ability and desire to effectively communicate simple and complex issues in written format or in person through face-to-face or virtual (Zoom/Microsoft Teams) environments.Working Conditions:This role is hybrid, part time on-site at our Seattle office.On-site work is performed in a typical office environment with standard office equipment available and used.Occasional business travel may be required.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 OpportunityAt 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 .
#J-18808-Ljbffr