Adverum Biotechnologies

Director, QA Systems (Contract)

Redwood City, CA · Director

Sponsorship not specifiedDetected 155 days ago

RecruitingGMPCRISPRResearchLeadershipCommunicationCollaborationPublic Speaking

About the role

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.
Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Assess and optimize Quality systems and processes for CMC, Clinical, Regulatory, and IT.
Drive complete cross-functional adoption of Quality systems and ensure excellence in execution and performance of the Quality systems through active participation and leadership.
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.
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.

Bachelor's degree in biological sciences or related field.
13+ years of progressive responsibility in the pharmaceutical industry, with demonstrated experience in Quality systems.
Expert knowledge of multi-regional regulatory requirements covering Quality systems.
Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance.
Ability to apply feedback to improve performance.
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.
experience and comfort interacting with staff at all organizational levels required.

This listing is sourced directly from Adverum Biotechnologies's careers page and normalized into a canonical job model.