Senior Audit Manager, QA

Location
Redwood City, CA
Posted
Apr 23, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a Senior Audit Manager, QA to join our team in our Redwood City office. This position reports to the Director of GxP Quality Assurance.   This person will work with cross functional team members.  Supporting all phases of clinical development programs to plan, control and improve the quality in accordance with US and Ex-US standards.

The Senior Audit Manager is responsible for executing quality audit programs (Internal, Systems, Vendors) and oversight of daily quality assurance activities supporting Quality Assurance related to compliance.  This position will be responsible to manage a team.

What you'll do:
  • Conduct Internal, Systems and Vendors audits
  • Perform GxP audits and timely audit report writing
  • Prepare and present audit findings
  • Monitor and track corrective and preventive actions resulting from audit findings
  • Develop and maintain audit plan, audit schedule and vendors list.
  • Ensure audit timelines are met within established limits and exp.ectations
  • Generate audit findings metrics and reporting
  • Support in company inspection readiness
  • Provide logistics support for regulatory agency inspections
  • Plan and review project timelines to ensure accurate and timely integration of audit activities
  • Serves as a Subject Matter Expert (SME) to operational departments on audits.
  • Effectively identify, describe, and communicate issues in a timely manner and ensure issues are resolved to closure.
  • Support other GxP functions as required, e.g. reviewing and negotiating quality agreements, performing vendor qualification.
  • Managing co -auditor and/or Consultant and their participation during the audit.
  • Perform quality audit SOP training.
  • Review and approve QA procedures
  • Other responsibilities as assigned

About you:
  • BS degree required and/or equivalent experience.
  • Minimum of ten (10) years of auditing experience preferred in Biotechnology, Pharmaceutical; and must have been part of the Quality, Compliance or Regulatory department.
  • Ability and drive for sound decision- making; pro-active approach.
  • Working knowledge and understanding of regulations; US required, and ex- US is desired.
  • Direct auditing experience and ability to travel approximately 25%
  • Strong auditing experience is required.
  • Ability to work effectively in a team environment with great organizational skills.
  • Possess excellent writing skills, effective interpersonal, verbal, and listening skills.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast -paced environment with high degree of flexibility.
  • Proficient with computers and word processing software (Microsoft Office products).

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