Hybrid Quality Assurance, Project Manager

at Adverum Biotechnologies

• Job title: Quality Assurance, Project Manager
• Job type: Contract
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Redwood City, United States

About the role

• Project Manager in Quality Assurance leading teams and ensuring compliance at Adverum. Demonstrating experience in pharmaceutical industry with focus on quality and regulatory requirements.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Other duties as assigned.