Gemini Bio
Senior Director of Quality
Gemini Bio, Sacramento, California, United States, 95828
Reports to:
Chief Scientific Officer (CSO)Company ProfileFounded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.Position SummaryThe Senior Director of Quality will oversee all quality aspects of the organization from Quality Assurance to Quality Control. The ideal candidate will define and implement the Quality Management System (QMS), including all quality policies and procedures pertaining to the cGMP manufacturing of products for the biotechnology industry. Additionally, this candidate will be responsible for overseeing the Quality Assurance and Quality Control teams, including the hiring, performance management, and professional development of managers/ supervisors and associates. This position will be responsible for the overall implementation and compliance of the Quality Management System, while simultaneously working cross functionally with business and operational functions to successfully deliver on our customer commitments. The Sr. Director will also interface directly with customers to understand customer needs, facilitate audits and questionnaires, and represent the organization’s QMS. The Sr. Director of Quality will manage with a strong sense of quality ownership, strategic thinking, creative thinking, and the drive to identify quality problems and develop effective and practical solutions while ensuring standards are achieved through continuous improvements.Key ResponsibilitiesDesign – and refine as needed – Quality Management System such that the QMS supports the organization’s business objectives and product categoriesOwnership / accountability to develop, implement and monitor adherence of quality management systems.Oversees quality control improvement efforts including Corrective and Preventive Action.Oversees development and implementation of quality control training programs for quality function and overall organization.Manage and/ or conduct internal and external audits and ensures compliance with company, and regulatory requirementsMonitor activities to ensure compliance with core quality measures.Gather, analyze and manage quality related data.Establish and Lead Vendor Quality assurance and Product certification programBuild a data-driven cultureWorkload and resource plan to ensure all high-level requirements can be delivered within required time frames.Recruit, develop and retain the Quality team including carrying out regular performance reviews with team members.Manage, mentor, and support the staff within the Quality departmentCore CompetenciesCustomer Centric
Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
Effective Teamwork
Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of teams.
Personal Leadership
Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
Planning and Organizing
Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.
Effective Communications
Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.
Expert at building, organizing, and managing diverse teams to accomplish challenging objectives – on time and under budget. Takes proactive steps to design and implement systems to effectively communicate team vision/ mission and cultivates the motivational atmosphere required to maximize the performance of everyone within the team.Execution Management
Expert at deploying tools and processes to bring clarity – and accountability – to the complex actions and deliverables required to accomplish the objective. Ruthlessly manages project deliverables, timelines, and results. Holds individuals and teams accountable to deliver on commitments.
Performance Management
Sets objectives and metrics with individuals and teams to ensure clarity regarding the desired outcomes and how success will be determined. Skillful in coaching – and supporting – individuals and teams. Able to quickly identify performance gaps, assess root cases, and implement corrective actions. Unsatisfied with poor performance and able to rigorously address performance barriers.
Business Acumen
Keen ability to understand how a business works, how the business delivers value to customers, how it makes money, and how strategies and decisions impact financial, operational, and sales results. Able to quickly understand the nuances and trade-offs associated with critical business issues, challenges, and opportunities, and make decisions that generate the greatest benefit to the business – and stakeholders.
Company ValuesIntegrity
Doing the right thing – the first time. Honoring and keeping commitments.
Intensity
Working with speed and focus to deliver the highest quality results – on time.
Involvement
Embracing unique perspectives and treating others with dignity and respect.
Biased to improve processes and products to better serve customers and improve workflows.Required Skills and ExperienceTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.BA/BS degree in the Chemistry, Biology, or a sciences-related field with a minimum of 10 years technical and/or quality experience in the Biopharmaceutical industry, preferred.Experience setting up or leading Quality departmentsWorking knowledge of FDA 21 CFR Part 210 and 211, ISO 13485, ICH Q7, 21 CFR Part 820Strong interpersonal skills and very resourcefulProven track record to manage Quality operations for a Biotechnology/ life sciences organizationKnowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) requiredFamiliarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as needed.Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process controlAptitude to work in a complex and rapidly growing companyAbility to develop and deliver communications to provide timely information for actionResults oriented, ensuring targets are met on time and on budgetKnowledge of Microsoft Office productsExcellent oral and written communication skillsEEO STATEMENTGeminiBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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Chief Scientific Officer (CSO)Company ProfileFounded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.Position SummaryThe Senior Director of Quality will oversee all quality aspects of the organization from Quality Assurance to Quality Control. The ideal candidate will define and implement the Quality Management System (QMS), including all quality policies and procedures pertaining to the cGMP manufacturing of products for the biotechnology industry. Additionally, this candidate will be responsible for overseeing the Quality Assurance and Quality Control teams, including the hiring, performance management, and professional development of managers/ supervisors and associates. This position will be responsible for the overall implementation and compliance of the Quality Management System, while simultaneously working cross functionally with business and operational functions to successfully deliver on our customer commitments. The Sr. Director will also interface directly with customers to understand customer needs, facilitate audits and questionnaires, and represent the organization’s QMS. The Sr. Director of Quality will manage with a strong sense of quality ownership, strategic thinking, creative thinking, and the drive to identify quality problems and develop effective and practical solutions while ensuring standards are achieved through continuous improvements.Key ResponsibilitiesDesign – and refine as needed – Quality Management System such that the QMS supports the organization’s business objectives and product categoriesOwnership / accountability to develop, implement and monitor adherence of quality management systems.Oversees quality control improvement efforts including Corrective and Preventive Action.Oversees development and implementation of quality control training programs for quality function and overall organization.Manage and/ or conduct internal and external audits and ensures compliance with company, and regulatory requirementsMonitor activities to ensure compliance with core quality measures.Gather, analyze and manage quality related data.Establish and Lead Vendor Quality assurance and Product certification programBuild a data-driven cultureWorkload and resource plan to ensure all high-level requirements can be delivered within required time frames.Recruit, develop and retain the Quality team including carrying out regular performance reviews with team members.Manage, mentor, and support the staff within the Quality departmentCore CompetenciesCustomer Centric
Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
Effective Teamwork
Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of teams.
Personal Leadership
Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
Planning and Organizing
Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.
Effective Communications
Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.
Expert at building, organizing, and managing diverse teams to accomplish challenging objectives – on time and under budget. Takes proactive steps to design and implement systems to effectively communicate team vision/ mission and cultivates the motivational atmosphere required to maximize the performance of everyone within the team.Execution Management
Expert at deploying tools and processes to bring clarity – and accountability – to the complex actions and deliverables required to accomplish the objective. Ruthlessly manages project deliverables, timelines, and results. Holds individuals and teams accountable to deliver on commitments.
Performance Management
Sets objectives and metrics with individuals and teams to ensure clarity regarding the desired outcomes and how success will be determined. Skillful in coaching – and supporting – individuals and teams. Able to quickly identify performance gaps, assess root cases, and implement corrective actions. Unsatisfied with poor performance and able to rigorously address performance barriers.
Business Acumen
Keen ability to understand how a business works, how the business delivers value to customers, how it makes money, and how strategies and decisions impact financial, operational, and sales results. Able to quickly understand the nuances and trade-offs associated with critical business issues, challenges, and opportunities, and make decisions that generate the greatest benefit to the business – and stakeholders.
Company ValuesIntegrity
Doing the right thing – the first time. Honoring and keeping commitments.
Intensity
Working with speed and focus to deliver the highest quality results – on time.
Involvement
Embracing unique perspectives and treating others with dignity and respect.
Biased to improve processes and products to better serve customers and improve workflows.Required Skills and ExperienceTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.BA/BS degree in the Chemistry, Biology, or a sciences-related field with a minimum of 10 years technical and/or quality experience in the Biopharmaceutical industry, preferred.Experience setting up or leading Quality departmentsWorking knowledge of FDA 21 CFR Part 210 and 211, ISO 13485, ICH Q7, 21 CFR Part 820Strong interpersonal skills and very resourcefulProven track record to manage Quality operations for a Biotechnology/ life sciences organizationKnowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) requiredFamiliarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as needed.Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process controlAptitude to work in a complex and rapidly growing companyAbility to develop and deliver communications to provide timely information for actionResults oriented, ensuring targets are met on time and on budgetKnowledge of Microsoft Office productsExcellent oral and written communication skillsEEO STATEMENTGeminiBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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