The Role
Lead optimization and implementation of Quality systems across CMC, Clinical, Regulatory, and IT to meet multi-regional regulatory requirements. Provide cross-functional leadership for integration with Eli Lilly, support audits and inspections, drive continuous improvement, present quality metrics, and ensure product supply integrity and GMP compliance.
Summary Generated by Built In
Adverum Biotechnologies, Inc., a 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. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
The Director of QA Systems is responsible for optimizing Quality systems to ensure adherence to late-stage clinical and commercial multi-regional regulatory requirements, as well as corporate quality objectives. The candidate will have demonstrated successful development, implementation, and execution of robust Quality systems and processes covering CMC, Clinical, Regulatory, and IT functions.
The individual must provide strategic leadership within internal and external CMC functions, along with cross-functional leadership at Eli Lilly, ensuring a successful integration process. This includes the ability to work independently and also as an effective and engaged cross-functional leader and team member in a fast-paced environment. Strong initiative and independent follow-through are essential for this role. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
What You'll Do:
- Assess and optimize Quality systems and processes for CMC, Clinical, Regulatory, and IT.
- Drive complete cross-functional adoption of Quality systems and ensure excellence in execution and performance of the Quality systems through active participation and leadership.
- 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.
- Represents Quality in both internal and external operational forums.
- Leads and participates in Quality function and cross-functional teams, focusing on ensuring success in accomplishing objectives through practice of Adverum values and behaviors.
- Leverages Continuous Improvement tools and processes to drive efficiencies in delivery of quality product and execution of the Quality Management System.
- Stays abreast of evolving multi-regional regulatory requirements and develops strategies to assess and update internal quality processes accordingly.
- Provides support for internal and regulatory audits and inspections.
- Develops and implements processes and criteria to assess effectiveness of quality initiatives.
- Supports 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 Quality systems.
- 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, US 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 (US and International).
- Demonstrate good judgement and escalate important issues to Sr. 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.
Skills Required
- Bachelor's degree in biological sciences or related field
- 13+ years of progressive responsibility in the pharmaceutical industry with demonstrated experience in Quality systems
- 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
- Strong organizational, management and cross-functional leadership skills
- Track record of effective collaboration, team effectiveness, and achievement of goals/deliverables
- Experience applying risk management principles to decision making
- Ability to write quality standards, standard operating procedures, work instructions, and reports
- Experience with ICH, US 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
- Comfortable in a fast-paced small company environment with minimal direction
- Ability to travel occasionally (US and International)
- Ability to maintain confidentiality and operate with high ethical standards
- Ability to make independent sound decisions and manage priorities independently
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The Company
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a 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. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
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