Adverum Biotechnologies, Inc.
Executive Director, Quality Assurance
Adverum Biotechnologies, Inc., Redwood City, California, United States, 94061
Adverum is looking for an Executive Director (ED) of Quality Assurance to join our team in our Redwood City office. The ED of QA is a strategic leader responsible for establishing a culture of quality at Adverum, overseeing the Adverum Quality Assurance department. This individual is a subject matter expert in the implementation and management of Quality Management Systems and has a comprehensive understanding of Clinical and Product compliance requirements for gene therapy products.Provides overall leadership and strategic development for GxP compliance functions, including GCP, GMP and GLP compliance, and establishes comprehensive quality processes and systems that support collaboration and compliance across an extended partner network. Partners and may lead development activities to coordinate and ensure support of GxP functions. Develops, implements and communicates a clear strategic vision for Quality to maximize employee focus, while maintaining a strong independent role for compliance-related decisions. Reviews existing policies and procedures, identifies gaps, and supports the development and communication of new and enhanced policies and procedures leading to compliant operations. Selects, develops, and evaluates personnel to ensure the efficient operation of the QA department.
What you'll do:
Provides overall leadership for the QA function to establish compliant processes and systems that support collaboration.Ensures personnel, processes, documentation and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.Identifies and assesses development quality risks and ensures they are evaluated and managed appropriately to accomplish regulatory and quality requirements.Formulates quality and compliance policies in coordination with corporate management and ensures that all required systems and standard operating procedures are in place and current.Ensures monitoring and auditing of development operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions.Fosters an environment of collaboration, trust, quality, innovation, and continuous improvement within the QA organization and with other functional departments.Develops and maintains effective working relationships within the organization.Identifies emerging trends/changes and redesigns processes and practices accordingly.Establishes, implements, and maintains performance metrics.Responsible for providing regular performance feedback, development, and coaching to direct reports.Develops and approves QA budgets and schedules to meet corporate requirements.Develops a robust quality system and fosters best practices across the organization.Other responsibilities assigned as needed.
About you:
BS or BA in Scientific Field; MS or Ph.D. in Scientific Field preferredA minimum of a Bachelor’s degree in a scientific discipline is required; an advanced degree is preferred. Equivalent experience may be accepted.A minimum of 15+ years of experience in the pharmaceutical or other related industry with at least 10 years of management experience.A minimum of 15 years working experience in a Quality environment with expert knowledge of compliance audits.Experience developing and managing late-stage clinical and commercial Quality Assurance organizations.Experience and oversight across clinical and commercial product divisions.Experience working in the fields of gene therapy, cell therapy, or another emerging therapeutic technology is highly desired.Comprehensive knowledge of GCP, GLP, GMP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development and commercialization.Demonstrated ability to provide leadership for significant quality policies, practices, and processes with respect to quality compliance.Experience with process improvement techniques and practices.Experience preparing for and successfully managing regulatory inspections.Demonstrated ability to anticipate and proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards).A self-starter with considerable managerial/leadership experience and a demonstrated ability to interact with various levels of management to accomplish goals and objectives.High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.Ability to partner with a diverse group of staff/consultants with different strengths and skills and ability to prioritize work, manage multiple projects, while maintaining quality.
$264,000 - $294,000 a year
The salary range for this position is $264,000 USD to $290,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
#J-18808-Ljbffr
What you'll do:
Provides overall leadership for the QA function to establish compliant processes and systems that support collaboration.Ensures personnel, processes, documentation and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.Identifies and assesses development quality risks and ensures they are evaluated and managed appropriately to accomplish regulatory and quality requirements.Formulates quality and compliance policies in coordination with corporate management and ensures that all required systems and standard operating procedures are in place and current.Ensures monitoring and auditing of development operations to identify potential compliance risk areas; recommends and assists with the implementation of enhancements to existing policies and procedures and other corrective actions.Fosters an environment of collaboration, trust, quality, innovation, and continuous improvement within the QA organization and with other functional departments.Develops and maintains effective working relationships within the organization.Identifies emerging trends/changes and redesigns processes and practices accordingly.Establishes, implements, and maintains performance metrics.Responsible for providing regular performance feedback, development, and coaching to direct reports.Develops and approves QA budgets and schedules to meet corporate requirements.Develops a robust quality system and fosters best practices across the organization.Other responsibilities assigned as needed.
About you:
BS or BA in Scientific Field; MS or Ph.D. in Scientific Field preferredA minimum of a Bachelor’s degree in a scientific discipline is required; an advanced degree is preferred. Equivalent experience may be accepted.A minimum of 15+ years of experience in the pharmaceutical or other related industry with at least 10 years of management experience.A minimum of 15 years working experience in a Quality environment with expert knowledge of compliance audits.Experience developing and managing late-stage clinical and commercial Quality Assurance organizations.Experience and oversight across clinical and commercial product divisions.Experience working in the fields of gene therapy, cell therapy, or another emerging therapeutic technology is highly desired.Comprehensive knowledge of GCP, GLP, GMP and other regulations for pharmaceuticals, along with an understanding of global quality standards and regulatory authority inspection trends in relation to product development and commercialization.Demonstrated ability to provide leadership for significant quality policies, practices, and processes with respect to quality compliance.Experience with process improvement techniques and practices.Experience preparing for and successfully managing regulatory inspections.Demonstrated ability to anticipate and proactively respond to trends and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards).A self-starter with considerable managerial/leadership experience and a demonstrated ability to interact with various levels of management to accomplish goals and objectives.High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.Ability to partner with a diverse group of staff/consultants with different strengths and skills and ability to prioritize work, manage multiple projects, while maintaining quality.
$264,000 - $294,000 a year
The salary range for this position is $264,000 USD to $290,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum,
Inclusion
and
Diversity
are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum
Community
to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.
#J-18808-Ljbffr