Bionova Scientific
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VP of Quality Compliance
role at
Bionova Scientific
Overview Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success is built on top scientific talent, the best available tools, and an energized culture focused on solving difficult client problems. We look for candidates with an innate desire to serve, adaptability, and an interest in transformative action.
Position Summary Bionova Scientific is seeking a
Vice President of Quality Compliance
to oversee all quality areas, including Quality Assurance, Quality Control, and Quality Systems. This role will manage client audits and drive proactive quality initiatives. The ideal candidate will demonstrate strong leadership in quality compliance and have prior experience with monoclonal antibodies and
E. coli
to effectively oversee and drive the quality agenda.
Primary Responsibilities
Lead the Quality Compliance organization, providing strategic and tactical direction and serving as final decision maker for quality matters, including release of commercial or investigational products.
Oversee the Quality Management System (QMS) activities: audit planning and execution, deviations, CAPAs, change controls, document control, cGMP validation, inspection readiness, issue management, process development, risk management, and training.
Evaluate quality compliance issues across all phases of commercial readiness and recommend solutions to business challenges.
Oversee QA aspects of vendor oversight, including audits, quality agreements, major deviation reviews, and batch disposition/release.
Plan and conduct internal and external audits to ensure regulatory compliance for clinical trials and investigational drug manufacturing; implement corrective actions to resolve findings.
Provide quality support to product development projects and support progression from clinical to commercial programs throughout their lifecycles.
Establish and maintain a robust compliance audit program for external and internal functions in cGMP responsibilities.
Lead quality activities for internal operations as well as contract manufacturers, contract laboratories, cGMP service providers, consultants, and partners.
Ensure appropriate staffing, ongoing education, and personnel development within the quality organization.
Create a positive, safe work environment and promote work-life balance.
Serve as final decision maker for product quality or compliance decisions, including release of materials and drug substances/products.
Represent Quality in executive discussions and with partners, health authorities, and corporate matters.
Integrate risk management into compliance and quality activities.
Develop and execute a comprehensive budget for quality operations, including expansion activities.
Collaborate with process development to provide analytical support for dynamic process decisions.
Define and pursue continuous improvement opportunities for QC laboratory operations.
Establish clear metrics and KPIs to monitor process performance and stability.
Provide leadership, coaching, and guidance to the team and communicate goals and results across development and commercial organizations.
Implement risk management within quality management of clinical and commercial products.
Build strong cross-functional relationships with Clinical Operations, Data Management, CMC, Regulatory, and Project Management.
Oversee EH&S functions.
Offer expert advice on quality compliance matters and assist in expanding the company's reach into viral vector and PDNA domains.
Working Conditions
Lab/office setting; ability to walk, stand, stoop, kneel, and crouch. May require lifting up to 20 pounds occasionally.
Required Skills and Qualifications
Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related field.
20+ years of experience leading and managing large teams in Quality Compliance, Quality Assurance, and Quality Systems.
Prior experience with monoclonal antibodies and E. coli is required.
Strong quality decision-making, leadership, and communication skills; proven success in biopharmaceuticals, especially large molecules.
Understanding of commercialization and commercial requirements of a CDMO, biologics processes, and US regulations.
Excellent written and oral communication; able to operate autonomously in a matrix environment and interact with executive leadership.
Influential, ethical, and with strong judgment.
Experience with analytical method validation and optimization for drug substance/product release and stability testing.
Experience applying analytical chemistry principles; extensive GMP knowledge.
Compensation and Benefits Compensation Range: The base range is between $243,000 and $260,000, with actual compensation depending on experience and qualifications.
Health Benefits: Health, dental, and vision insurance; 100% company-paid life insurance and disability.
Retirement: 401(k) with up to 8% employer match.
Paid time off: Up to two weeks, plus 10 holidays and 5 days of sick leave.
Equal Opportunity Employer: Asahi Kasei believes a diverse workforce supports our ability to adapt to changes in the economy, society, and environment.
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Referrals increase your chances of interviewing at Bionova Scientific. Get notified about new Vice President of Quality jobs in Fremont, CA.
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VP of Quality Compliance
role at
Bionova Scientific
Overview Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success is built on top scientific talent, the best available tools, and an energized culture focused on solving difficult client problems. We look for candidates with an innate desire to serve, adaptability, and an interest in transformative action.
Position Summary Bionova Scientific is seeking a
Vice President of Quality Compliance
to oversee all quality areas, including Quality Assurance, Quality Control, and Quality Systems. This role will manage client audits and drive proactive quality initiatives. The ideal candidate will demonstrate strong leadership in quality compliance and have prior experience with monoclonal antibodies and
E. coli
to effectively oversee and drive the quality agenda.
Primary Responsibilities
Lead the Quality Compliance organization, providing strategic and tactical direction and serving as final decision maker for quality matters, including release of commercial or investigational products.
Oversee the Quality Management System (QMS) activities: audit planning and execution, deviations, CAPAs, change controls, document control, cGMP validation, inspection readiness, issue management, process development, risk management, and training.
Evaluate quality compliance issues across all phases of commercial readiness and recommend solutions to business challenges.
Oversee QA aspects of vendor oversight, including audits, quality agreements, major deviation reviews, and batch disposition/release.
Plan and conduct internal and external audits to ensure regulatory compliance for clinical trials and investigational drug manufacturing; implement corrective actions to resolve findings.
Provide quality support to product development projects and support progression from clinical to commercial programs throughout their lifecycles.
Establish and maintain a robust compliance audit program for external and internal functions in cGMP responsibilities.
Lead quality activities for internal operations as well as contract manufacturers, contract laboratories, cGMP service providers, consultants, and partners.
Ensure appropriate staffing, ongoing education, and personnel development within the quality organization.
Create a positive, safe work environment and promote work-life balance.
Serve as final decision maker for product quality or compliance decisions, including release of materials and drug substances/products.
Represent Quality in executive discussions and with partners, health authorities, and corporate matters.
Integrate risk management into compliance and quality activities.
Develop and execute a comprehensive budget for quality operations, including expansion activities.
Collaborate with process development to provide analytical support for dynamic process decisions.
Define and pursue continuous improvement opportunities for QC laboratory operations.
Establish clear metrics and KPIs to monitor process performance and stability.
Provide leadership, coaching, and guidance to the team and communicate goals and results across development and commercial organizations.
Implement risk management within quality management of clinical and commercial products.
Build strong cross-functional relationships with Clinical Operations, Data Management, CMC, Regulatory, and Project Management.
Oversee EH&S functions.
Offer expert advice on quality compliance matters and assist in expanding the company's reach into viral vector and PDNA domains.
Working Conditions
Lab/office setting; ability to walk, stand, stoop, kneel, and crouch. May require lifting up to 20 pounds occasionally.
Required Skills and Qualifications
Advanced degree in Pharmaceutics, Biochemistry, Physical Chemistry, Organic Chemistry, Biochemical Engineering, or related field.
20+ years of experience leading and managing large teams in Quality Compliance, Quality Assurance, and Quality Systems.
Prior experience with monoclonal antibodies and E. coli is required.
Strong quality decision-making, leadership, and communication skills; proven success in biopharmaceuticals, especially large molecules.
Understanding of commercialization and commercial requirements of a CDMO, biologics processes, and US regulations.
Excellent written and oral communication; able to operate autonomously in a matrix environment and interact with executive leadership.
Influential, ethical, and with strong judgment.
Experience with analytical method validation and optimization for drug substance/product release and stability testing.
Experience applying analytical chemistry principles; extensive GMP knowledge.
Compensation and Benefits Compensation Range: The base range is between $243,000 and $260,000, with actual compensation depending on experience and qualifications.
Health Benefits: Health, dental, and vision insurance; 100% company-paid life insurance and disability.
Retirement: 401(k) with up to 8% employer match.
Paid time off: Up to two weeks, plus 10 holidays and 5 days of sick leave.
Equal Opportunity Employer: Asahi Kasei believes a diverse workforce supports our ability to adapt to changes in the economy, society, and environment.
Seniority level
Executive
Employment type
Full-time
Job function
Quality Assurance
Referrals increase your chances of interviewing at Bionova Scientific. Get notified about new Vice President of Quality jobs in Fremont, CA.
#J-18808-Ljbffr