QA Specialist III (CMC Data Reviewer)

Location
Redwood City, CA
Posted
May 31, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for a QA Specialist III, CMC to join our team in our Redwood City office. This position reports to the Associate Manager, QA Lot Disposition. This person will be working with cross-functional team members. This position will support the Quality Chemistry Manufacturing Controls (CMC) Bulk Drug Substance, Drug Products, Excipients, and Packaging Materials, including Regulatory Affairs, Process Science, and Assay Development.

The QA Specialist III will perform the Quality Compliance (QC) review of the CMC sections of IND submission, IND Amendments, Annual Report, and all regulatory agency submissions QC review. And 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.

What you'll do:
  • Support cross-functional QC review for the CMC documents
  • Provide QA’s perspective and expertise in the non-clinical development team, CMC team, and other teams.
  • Ensure Regulatory compliance and quality requirements are met by checking, reviewing all Regulatory submissions of CMC section.
  • Ensure alignment of product changes and collaborate with key colleagues to develop a strategy that maintains supply while improving product robustness.
  • Support CMC section by driving clarity and consistency of product specifications.
  • Support product transition from clinical to commercial, new product introduction, technology transfers, and method transfers.
  • Perform review of CMC documents in compliance with US FDA, ICH, and international health agency requirements as appropriate.
  • Independently reviews and approves technology reports, analytical data, test records, stability data.
  • Represents QA and provides support to internal team meetings as needed.
  • Performs quality systems metrics.
  • Initiates and updates SOPs as required.
  • Other responsibilities as assigned.

About you:
  • BS degree required and/or equivalent experience and qualification.
  • Minimum of seven (7) years professional experience in Biotechnology, and Pharmaceutical
  • Ability and drive for sound decision-making and pro-active approach.
  • Working knowledge and understanding of regulations; US required, and ex-US is desired.
  • Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment.
  • Advance scientific and technical expertise in the area of CMC, GMP, and regulatory affairs.
  • Sound analytical and strategical skills together with the ability to present complex facts and provide efficient solutions.
  • Ability to work effectively in a team environment with great organizational skills.
  • Possess a high level of social/interpersonal as well as communication 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 a 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