MANAGER/SENIOR MANAGER, QUALITY ASSURANCE OPERATIONS

Quality Assurance Pleasanton, CA


Description

Position Summary:

Manager/Senior Manager, Quality Assurance Operations will support the quality oversight for the internal and external GMP clinical Manufacturing which includes executed Batch Record review, preparing lot package and batch disposition, participate in investigation of deviation, CAPA and management of change control process.  This position will also provide Quality review of Master Batch Records which include eBR and associated Quality Control documentation for the production of GMP products.  Additionally, this position will support supplier quality including raw material inspection/release and maintaining the eQMS system.

Responsibilities:

The Manager/Senior Manager, Quality Assurance Operations supports the drug substance and drug product manufacturing process with the following responsibilities:

  • Review executed Batch Records including eBR and prepared the lot package for batch disposition.
  • Maintain a batch record review schedule to ensure on-time product disposition.
  • Interface with cross functional teams including internal and external (CMO) manufacturing as necessary to provide quality oversight of GMP Manufacturing by providing QA input, address any comments or corrections identified during the QA review process.
  • Participating or leading deviation investigation, CAPA and Change Management process and ensure timely and proper closure of deviation/CAPA/Change Controls.
  • Responsible for the development and maintenance of processes and procedures supporting Quality Management System (QMS).
  • Perform and support Suppler Quality Management – raw materials inspection/release and supplier qualification activities.
  • Participate in the review and data verification of regulatory documents.
  • Drive continuous improvement utilizing quality tools to improve quality compliance
  • Collaborate with internal and external teams to support and guide with quality operational activities.
  • Other duties as assigned.
Requirements:

Minimum Education/Experience
  • Bachelor’s degree (or equivalent), preferably in scientific discipline or a health-related field
  • Minimum 5 to 7 years of experience in GMP manufacturing, Quality Assurance and reviewing Batch Documentation in a GMP environment (biotechnology, Pharmaceutical and Cell therapy operation)
  • Working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents
  • GCP and GLP knowledge and experience
  • Knowledge and experience in biotech/pharmaceutical quality system – eQMS
  • Ability to interpret and relate quality standards implementation
Qualifications:
  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment
  • Self-motivated, self-disciplined and able to function independently as well as part of a team
  • Strategic agility, strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)