Quality System Specialist II/III

Location
Redwood City, CA
Posted
Apr 18, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Our Quality Assurance team is looking to bring onboard a Quality Systems Specialist II/III. This individual will perform and maintain Quality Assurance (QA) programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and disposition of clinical materials manufactured at Contract Service Providers
What you'll do:
  • Track quality metrics for Quality Management System processes, analyze data and coordinate quality continuous improvement activities.
  • Support risk management-based approaches.
  • Review and track deviations and investigations related to material disposition.
  • Represent QA on cross-functional teams to complete projects, address quality issues and identify quality system improvements.
  • Develop or review quality processes supporting change management and ensuring compliance with current Good Manufacturing Practice (cGMP) requirements.
  • Assist in the review and approval of manufacturing documents for clinical products in compliance with US and international health agency requirements as needed.
  • Coordinate, lead and conduct internal investigations as well as investigations at contract service providers as needed.
  • Advocate and maintain quality systems and policies throughout the company.
  • Assist in additional quality functions as needed.

About you:
  • BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience.
  • Minimum 4 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 key quality systems (e.g., Change Management, Vendor Management, Deviations/CAPA, and Management Review); experience with electronic systems is a plus.
  • Experience developing and reporting quality metrics.
  • Excellent working knowledge and understanding of GxP requirements, proficiency in applying regional regulatory and ICH guidelines. Broad experience in the bio-pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D experience a plus.
  • Excellent working knowledge of quality systems and GxP standards applicable to product life cycle from development to commercial.
  • 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 and vendors.
  • 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 in a fast pace environment
  • 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