QA Compliance Manager

Adverum Biotechnologies, Inc. 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. 

Adverum is looking for a QA Compliance Manager to support ongoing GxP Quality Compliance activities such as Vendor Oversight, Internal Audits, Inspection Readiness, Operational Excellence and Regulatory Intelligence. This is a position within the Quality Assurance Team which requires collaboration with multiple internal and external stakeholders. Auditing experience is required. Strong problem-solving, communication, and organizational skills are essential for an individual to be successful in this role. This position is hybrid with an expectation to be on-site at least 2 days a week.

What you’ll do:

• Support a wide variety of GxP activities associated with Adverum’s quality compliance initiatives. 
• Provide risk-based quality oversight to vendor qualification activities and ensure compliance with internal procedures and documentation.
• Create and manage vendor audit schedules. Conduct audits when requiredand interact with vendors to ensure compliance with internal requirements. Ensure vendor packages are complete and inspection ready.
• Manage internal audit program, conduct internal audits, and ensure compliance with quality objectives and regulatory requirements.
• Assist with regulatory inspections and oversee the inspection readiness plan. Support inspection readiness activities, as directed by QA management.
• Support and lead continuous improvement initiatives.
• Manage Regulatory intelligence activities and communicate internally. Create action plans and manage completion of change relevant activities.
• Support the development and maintenance of the Quality Management System and procedures. 
• Escalate quality and compliance issues to QA Management in a timely manner and ensure issues are resolved to closure. 
• Works closely with other functions to assure consistency and implementation of best practices. 
• Foster a quality culture and compliance within the team, promoting teamwork, accountability, and continuous learning. 
• Perform other responsibilities as assigned by QA management. 

About you:

• Bachelor’s degree in biological sciences or related field; Master’s degree preferred. 
• 10 years progressive Quality Assurance and GxP compliance experience in a pharmaceutical, biologics or advanced therapies.
• Working knowledge and understanding of ICH, US FDA, EU and other relevant regulations.
• Direct auditing experience is required. Certified Quality Auditor certification is preferred.
• Strong organizational and cross-functional project management skills.
• Ability to work and communicate effectively in a team environment with great organizational skills that enables risk-based quality management and a culture of quality and open dialogue. 
• Possess effective interpersonal, verbal, and listening skills. 
• Must be an individual with proven initiative, demonstrated accountability, and ability to manage multiple priorities in a fast-paced environment with high degree of flexibility. 
• Ability to write standard operating procedures, work instructions, reports, etc. 
• Ability to travel occasionally. 
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise. 

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation.