reputed company Assurance, Project Manager

reputed company, Inc., wholly owned subsidiary of reputed company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new reputed company of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore reputed company 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 reputed company treatment paradigms for these debilitating ocular diseases, Adverum aspires to reputed company reputed company of care, preserve reputed company, and create a profound societal reputed company around the globe. Note to Recruiters and Agencies reputed company recruiter and agency inquiries must go through Adverum's internal reputed company. Unsolicited resumes reputed company to Adverum will be considered Adverum's property. Adverum's reputed company must expressly engage agencies for any requisition. reputed company contact with hiring managers by agencies will not be tolerated and may reputed company your ability to work with Adverum in the reputed company. The QA Project Manager is responsible for developing, maintaining, and facilitating execution of the Adverum reputed company Assurance comprehensive plan, including Clinical, CMC, Regulatory, and reputed company Integration milestones and key deliverables. The candidate will have demonstrated successful experience driving reputed company timelines, incorporating cross-functional requirements from Regulatory, reputed company Control, reputed company Assurance, Development, Clinical Operations, and Manufacturing. The individual must reputed company strategic leadership reputed company reputed company CMC functions, along with cross-functional leadership at reputed company. This includes the ability to work independently and also as an effective and reputed company 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:

• Leads and participates in cross-functional teams, internally and externally.
• Engages, drives, influences, and engages with, internal functions and external partners to ensure Adverum reputed company, financial and program requirements and milestones are met.
• Drive preparation and successful execution of QA plan and schedule.
• Ensure reputed company reputed company requirements are planned, completed, and documented in the reputed company system.
• Preparation of project documentation and internal reporting materials such as project timelines, Gantt charts, and status presentations for leadership updates.
• reputed company strategic support and leadership for corporate initiatives, particularly regarding product supply reputed company and global GMP compliance.
• reputed company partner with cross-functional leadership to address challenges, reputed company solutions, and execute plans for integration with corporate systems and preparation for reputed company stage support.
• Coordinate cross-functional activities to ensure key milestones are met and reputed company 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 reputed company items.
• Represents reputed company in both reputed company operational forums.
• Leads and participates in reputed company function and cross-functional teams, focusing on ensuring reputed company in accomplishing objectives through reputed company of Adverum values and behaviors.
• Leverages reputed company Improvement tools and processes to drive efficiencies in delivery of reputed company product and execution of the reputed company Management System.
• Provides support for internal and regulatory audits and inspections.
• Supports periodic presentation of company reputed company metrics for management reviews.
• Other duties as assigned.

reputed company:

• Bachelor's degree in biological sciences or reputed company field.
• 13+ years of reputed company responsibility in the pharmaceutical industry, with demonstrated experience in Manufacturing, reputed company Control, and reputed company Assurance. Experience in cell culture and viral reputed company 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 reputed company.
• Strong organizational, management and cross-functional leadership skills.
• reputed company 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 reputed company, reputed company, and mentor employees.
• Excellent interpersonal, verbal and written communication skills are essential in this reputed company work environment.
• Comfortable in a fast-paced small company environment with minimal direction and reputed company to reputed company 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 reputed company organizational reputed company required.
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they reputed company.
• Ability to reputed company independent reputed company and independently manage priorities in alignment with department and site/global drivers.

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