QA Manager, Document Control
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 Manager, Document Control reporting to the Sr. QA Manager, Master Control Project Administrator. In this role you will perform various duties essential to the maintenance and/or support of Document Control and Adverum’ s quality systems including System Administration of MasterControl EQMS, training, deviations, CAPAs, Change Control, Lot Disposition, Product Complaints, and other duties as assigned by Adverum’ s QA department.
What You’ll Do:
- Assisting with system administration of MasterControl EQMS.
- Lifecycle management of controlled documents including creation, review, approval, and retirement per the internal QMS and SOPs.
- Lifecycle management of training courses including creation, review, approval, and retirement.
- Support version upgrades and continuous improvement efforts of MasterControl, including configuration and testing of new modules.
- Train current users and new users on MasterControl roles.
- Support resolving system related issues, and ensuring records are processed according to procedures and guidelines.
- Troubleshoot and provide solutions to challenges in the MasterControl EQMS.
- Prepare quality metrics and report.
- Provide staff support regarding quality systems, including maintenance of logs, facilitating timely closure of records and providing QA review as appropriate.
- Facilitate the document change request process, including providing formatting assistance, coordinating the review/approval process, tracking and routing of controlled documents.
- Manage the Document Control room, ensuring data integrity and inspection readiness.
- Maintain electronic and hardcopy history files of controlled documents, ensuring accurate and reliable filing systems.
- Initiates updates and creation of new SOPs as required.
- Copy, scan, and distribute controlled documents as needed.
- Issue, track and/or reconcile controlled test record forms, logbooks and laboratory notebooks.
About You:
- Minimum of a bachelor’s degree in a Life Science preferred or other relevant discipline with 7+ years of work experience with electronic document management system, with 5 years of Document Control, Training Management, or Quality System experience.
- Experience with implementation/maintenance of electronic document management systems, curriculum design, and training.
- Must be proficient in MS Office (Word, Excel, PowerPoint) and Adobe Acrobat.
- Knowledge of GMP regulations is required.
- Must be able to communicate well with all levels of staff.
- Strong critical thinking, problem-solving, and exceptional attention to detail.
- Ability to manage and prioritize multiple projects/tasks, with minimal supervision, and adapt to changing priorities.
Salary Range: The salary range for this position is $130,000 USD to $145,000 USD annually, with the opportunity to earn an annual bonus. This salary range is an estimate, and the actual salary may vary based on a candidate’s qualifications, including education, length of experience, location, and market data. Employees in this position are eligible to participate in the applicable Company equity incentive award plan. The amount of incentive varies and is subject to the terms and conditions of the plan. Employees in this position are eligible to participate in the Company’s standard employee benefit programs, which currently include the following: medical, dental, vision, 401k, STD/LTD, life and accident insurance, and either paid time off or flexible paid time off.
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.