Director, QA Validation

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.

The Director of QA Validation is responsible for developing and leading corporate-wide validation programs 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 validation processes covering production, analytics, facility, and computer systems. 

The individual must provide strategic leadership within internal and external CMC functions. 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. 

• Develop and implement validation programs and processes for production, analytical, facility and CSV functions.
• 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.
• 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.

• Bachelor’s degree in biological sciences or related field.
• 13+ years of progressive responsibility in validation experience in the pharmaceutical industry, demonstrated experience in production and analytical validation preferred.
• Expert knowledge of multi-regional regulatory requirements covering production, analytical, facility and computerized system validation areas.
• 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.

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.