Manager – Quality Control
Compliance
Updated on 2/5/2024
AGC Biologics

1,001-5,000 employees

Customized biopharmaceutical production and development services
Company Overview
AGC Biologics stands out as a global leader in the biopharmaceutical Contract Development and Manufacturing Organization (CDMO) sector, offering specialized services for the scale-up and cGMP manufacture of protein-based therapeutics and other complex biologics. The company's proprietary CHEF1™ Expression System for efficient protein production, coupled with its commitment to delivering reliable and compliant drug substances, underscores its technical prowess and competitive edge. With cGMP-compliant facilities across the US, Europe, and Japan, AGC Biologics not only ensures global reach but also fosters strong partnerships with customers, aiding them in accelerating their projects and managing product lifecycle costs.
Biotechnology

Company Stage

Series C

Total Funding

$613M

Founded

2001

Headquarters

Bothell, Washington

Growth & Insights
Headcount

6 month growth

3%

1 year growth

5%

2 year growth

22%
Locations
Seattle, WA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Legal & Compliance
Requirements
  • Extensive experience with Quality Systems and Regulatory Inspections
  • Detailed understanding of data integrity requirements for GMP operations, including 21CFR Part 11
  • Strong organizational and project management skills
Responsibilities
  • Oversee QC compliance team and provide training to staff
  • Provide subject matter expertise to prepare for internal audits and regulatory agency inspections
  • Provide oversite of QC responses to audits and inspections and coordinate resulting CAPAs as necessary
  • Provide oversite of QC contribution to APR and QMR including metric development
  • Oversee and mature laboratory investigations, deviations, and CAPAs
  • Oversee and mature departmental training program
  • Oversee and mature departmental data integrity program
  • Drive continuous improvement to related processes
  • Develop and coach staff in alignment with company goals and individual career aspirations
Desired Qualifications
  • Master’s degree with 3+ years of industry experience