Associate Director of External QA (Finished Goods) (Contract)
Adverum Biotechnologies, Inc., Redwood City, CA, United States
About the Company
Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single‑administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. Director of External QA
The AD/Director of External QA is responsible for ensuring Adverum Finished Goods are manufactured and distributed by contract manufacturing organizations and distributors in adherence to late-stage clinical and commercial multi-regional regulatory requirements, as well as corporate quality objectives. The candidate will have demonstrated successful experience in quality oversight of external manufacturing operations, including the representation of cross-functional requirements from Regulatory, Quality Control, Development, Project Management, and Manufacturing. What you’ll do
Lead and participate in cross‑functional production teams, internally and externally. Engage, drive, influence, and lead product teams, internal functions, and external partners to ensure Adverum quality, manufacturing, financial and program requirements and milestones are met. Drive preparation and successful execution of PPQ and comparability production campaigns. Ensure all quality requirements are planned, completed, and documented in the quality system. Lead critical investigations, develop and oversee implementation of effective CAPA. Provide strategic support and leadership for corporate initiatives, particularly regarding product supply integrity and global GMP compliance. Actively partner with cross‑functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support. Represent quality in both internal and external operational forums. Lead and participate in quality function and cross‑functional teams, focusing on ensuring success in accomplishing objectives through the practice of Adverum values and behaviors. Leverage continuous improvement tools and processes to drive efficiencies in delivery of quality product and execution of the quality management system. Stay abreast of evolving multi‑regional regulatory requirements and develop strategies to assess and update internal quality processes accordingly. Provide support for internal and regulatory audits and inspections. Develop and implement processes and criteria to assess effectiveness of quality initiatives. Support periodic presentation of company quality metrics for management reviews. Other duties as assigned. About you
Bachelor’s degree in biological sciences or related field. 13+ years of progressive responsibility in the pharmaceutical industry, with demonstrated experience in manufacturing, quality control, and quality assurance. Experience in cold and ultra‑cold chain is preferred. Expert knowledge of multi‑regional regulatory requirements covering quality systems. Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance. Demonstrated consistent accuracy and thoroughness. Ability to apply feedback to improve performance. Monitors own work to ensure quality. Strong organizational, management, and cross‑functional leadership skills. Track record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables. Experience applying risk management principles to decision making. Ability to write quality standards, standard operating procedures, work instructions, reports, etc. Experience with ICH, U.S. and EU regulatory requirements. Previous experience presenting and responding to regulatory agency audits. Demonstrated ability to develop, coach, and mentor employees. Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment. Comfortable in a fast‑paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to travel occasionally (U.S. and International). Demonstrate good judgement and escalated issues to senior management; experience and comfort interacting with staff at all organizational levels required. Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise. Ability to make independent sound decisions and independently manage priorities in alignment with department and site/global drivers. Compensation
$100 - $110 an hour Equal Employment Opportunity
Adverum Biotechnologies, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status.
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Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single‑administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. Director of External QA
The AD/Director of External QA is responsible for ensuring Adverum Finished Goods are manufactured and distributed by contract manufacturing organizations and distributors in adherence to late-stage clinical and commercial multi-regional regulatory requirements, as well as corporate quality objectives. The candidate will have demonstrated successful experience in quality oversight of external manufacturing operations, including the representation of cross-functional requirements from Regulatory, Quality Control, Development, Project Management, and Manufacturing. What you’ll do
Lead and participate in cross‑functional production teams, internally and externally. Engage, drive, influence, and lead product teams, internal functions, and external partners to ensure Adverum quality, manufacturing, financial and program requirements and milestones are met. Drive preparation and successful execution of PPQ and comparability production campaigns. Ensure all quality requirements are planned, completed, and documented in the quality system. Lead critical investigations, develop and oversee implementation of effective CAPA. Provide strategic support and leadership for corporate initiatives, particularly regarding product supply integrity and global GMP compliance. Actively partner with cross‑functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support. Represent quality in both internal and external operational forums. Lead and participate in quality function and cross‑functional teams, focusing on ensuring success in accomplishing objectives through the practice of Adverum values and behaviors. Leverage continuous improvement tools and processes to drive efficiencies in delivery of quality product and execution of the quality management system. Stay abreast of evolving multi‑regional regulatory requirements and develop strategies to assess and update internal quality processes accordingly. Provide support for internal and regulatory audits and inspections. Develop and implement processes and criteria to assess effectiveness of quality initiatives. Support periodic presentation of company quality metrics for management reviews. Other duties as assigned. About you
Bachelor’s degree in biological sciences or related field. 13+ years of progressive responsibility in the pharmaceutical industry, with demonstrated experience in manufacturing, quality control, and quality assurance. Experience in cold and ultra‑cold chain is preferred. Expert knowledge of multi‑regional regulatory requirements covering quality systems. Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance. Demonstrated consistent accuracy and thoroughness. Ability to apply feedback to improve performance. Monitors own work to ensure quality. Strong organizational, management, and cross‑functional leadership skills. Track record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables. Experience applying risk management principles to decision making. Ability to write quality standards, standard operating procedures, work instructions, reports, etc. Experience with ICH, U.S. and EU regulatory requirements. Previous experience presenting and responding to regulatory agency audits. Demonstrated ability to develop, coach, and mentor employees. Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment. Comfortable in a fast‑paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to travel occasionally (U.S. and International). Demonstrate good judgement and escalated issues to senior management; experience and comfort interacting with staff at all organizational levels required. Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise. Ability to make independent sound decisions and independently manage priorities in alignment with department and site/global drivers. Compensation
$100 - $110 an hour Equal Employment Opportunity
Adverum Biotechnologies, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status.
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