Quality Assurance, Project Manager

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. 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 Adverum's property.   Adverum’s Talent Acquisition team must expressly engage agencies 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 QA Project Manager is responsible for developing, maintaining, and facilitating execution of the Adverum Quality Assurance comprehensive plan, including Clinical, CMC, Regulatory, and Eli Lilly Integration milestones and key deliverables.  The candidate will have demonstrated successful experience driving complex timelines, incorporating cross-functional requirements from Regulatory, Quality Control, Quality Assurance, Development, Clinical Operations, and Manufacturing.

The individual must provide strategic leadership within internal and external CMC functions, along with cross-functional leadership at Eli Lilly. 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. 

• Leads and participates in cross-functional teams, internally and externally.
• Engages, drives, influences, and engages with, internal functions and external partners to ensure Adverum Quality, financial and program requirements and milestones are met.
• Drive preparation and successful execution of QA plan and schedule.
• Ensure all quality requirements are planned, completed, and documented in the Quality system.
• Preparation of project documentation and internal reporting materials such as project timelines, Gantt charts, and status presentations for leadership updates. 
• 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.
• Coordinate cross-functional activities to ensure key milestones are met and projects remain on schedule. 
• Identify risks, dependencies, and potential delays and escalating as needed. 
• Facilitate team and cross-functional meetings, including agenda preparation, documentation of meeting minutes, and tracking of action items. 
• 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.
• Provides support for internal and regulatory audits and inspections.
• Supports periodic presentation of company quality metrics for management reviews.
• Other duties as assigned.

• 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 cell culture and viral vector manufacturing platforms preferred.
• 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.
• Experience with ICH, US and EU Regulatory Requirements.
• 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.