AD/Director Global GMP QA, Large Molecule Operations

Company: Ascent Services Group
Location: Emeryville
Posted on: April 10, 2021

Job Description:

AD/Director Global GMP QA, Large Molecule Operations AD/Director Global GMP QA, Large Molecule Operations
Emeryville, CA (Remote potential)
General Description
The Director, GMP QA Large Molecules is responsible for overseeing end to end quality operational activities and programs related to large molecule manufacturing (including CMOs), develops, interprets, and implements quality policies, author procedures, author sections of BLA, and supports regulatory compliance inspections. Manages QA operational activities that support GMP manufacturing, testing and release of finished biological products under FDA regulations, applicable International Regulations, ICH standards, and processes procedures. Essential Functions of the job:

• Supports development and management of Large Molecules Operations, QA program, systems, policies, procedures and controls to ensure that-- biological products conform to established standards and regulatory agency requirements
• Work with CMO and internal staff to ensure the end to end manufacturing processes remain in a compliant state, and final product meets all required standards and specifications
• Work with regulatory and CMC to establish Process Performance Qualification for Large Molecule Products
• Work with regulatory to Author and Review pertinent sections of a BLA application.
• Support CMC with Large Molecule Manufacturing and Implementation of Process Validation
• Work with regulatory in providing technical responses to FDA quires.
• Manage documentation, reporting and closure of biological product related compliance issues
• Author Standard Operating Procedures related to function and department
• Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements
• Oversee the following investigations: nonconforming product, customer complaint, laboratory OOS and CAPA. Ensure all investigations are performed and closed in timely fashion Core Competencies, Knowledge and Skill Requirements
  • Practical Experience in the authorship and review of a BLA application
  • Practical experience in establishing Process Performance Qualification for Large Molecule Products
  • Practical Experience in Large Molecule Manufacturing and Process Validation
  • Technical Knowledge and experience in Large Molecule DS Manufacturing
  • Technical knowledge and Experience in Sterile Manufacturing
  • Practical experience in providing technical responses to FDA quires
  • Working knowledge of GMP regulations and experience with regulatory compliance inspections
  • Working knowledge and experience with 21CFR210, 21CFR211, ICHQ7 as well as international regulations
  • Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems
  • Ability to effectively lead teams and manage staff
  • Must possess strong presentation skills to speak effectively before groups; ability to respond Communication & Interpersonal Skills
    • Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail
    • Interacts with all levels of--employees; CMOs Supervisory Responsibilities:
      • Manage direct reports globally Education Required
        • Bachelor of Science Degree in a related scientific discipline Experience
          • 15+ years of experience in the biotechnology pharmaceutical industry
          • 10+ years of experience in quality assurance role, 8 of which includes management experience
          • Strong knowledge and experience with GxP regulations
          • Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems
          • Ability to effectively lead teams and manage staff Job Type: Direct Placement
            Location: Emeryville, CA
            Job ID: 21-03151
            Date Updated: April 5, 2021 Brierly Lindberg is recruiting for this position. Corporate Office
            1001 Galaxy Way, Suite 405
            Concord, CA 94520
            925-627-4900
            info@ascentsg.com Employment Verifications
            Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, San Francisco , AD/Director Global GMP QA, Large Molecule Operations, Executive , Emeryville, California