QA Manager Computer Software Validation

Our Quality Assurance team is looking to bring onboard a QA Manager, Computer System Validation. This individual is responsible for software quality oversight and execution of system validation and verification efforts supporting computerized systems and ensuring compliance to quality objectives and regulatory requirements. 

About You

What you'll do:

• Provide software QA and validation leadership for computerized systems.
• Work on compliance efforts with 21CFR Part 11, EU Annex 11
• Oversee software QA and validation strategy in support of custom software systems including configuration workflow, analytics to improve the overall accuracy, efficiency and effectiveness.
• Manage and provide guidance for organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Identify and resolve complex systems issue and effectively communicates gating items.
• Support the external audit program related computerized systems, and the software and computer system validation SME in cross functional project teams.
• Evaluate and recommend QA process changes based on requirements for compliance.
• Represent QA on cross-functional teams to complete projects, address issues and identify quality improvements.
• Create procedure. for QA computer system validation process
• Provide training on Computerized Systems Validation regulatory requirements.
• Other responsibilities as assigned.

About you:

• BS degree in Computer Science, or related field and/or equivalent experience.
• Minimum 10 years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment, preferably in an advanced therapy such as gene therapy.
• Detail-oriented with a QA background. Ability to work effectively in a team environment with exceptional organizational skills.
• Direct experience with validation methodology and software development life cycle
• Expertise and working knowledge of 21CFR Part 11 and EU Annex 11.
• Managing software validation teams,
• Excellent working knowledge and understanding of computer validation regulatory requirements.
• Broad experience in the bio-pharmaceutical industry.
•  Ability to prioritize and coordinate with other functions in order to meet deadlines efficiently.
• Ability to provide internal training with excellent public speaking skills.
• A self-starting, highly motivated individual with strong interpersonal and communications skills, both verbal and written, to provide clear direction for internal stakeholders.
• Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility.
• Proficient with the Microsoft Office software, including Word, Excel, PowerPoint. Experience with Project a plus.
• Possess positive attitude, with good organizational skills.
• Ability to work independently with minimal instruction. 

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

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