Director Quality Control

San Francisco, California
Mar 27, 2018
Required Education
Bachelors Degree
Position Type
Full time


Quality Control

Reporting To

Senior Director, Analytical Development and Quality Control

Job Purpose

This position is responsible for all QC activities onsite, and at Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs) for manufacturing GMP lots for PIII trials, BLAs and commercial. In addition, the Director of QC will be responsible for ensuring that SillaJen, CMOs, CTLs and suppliers of critical components are prepared for PAI with FDA and other regulatory authorities worldwide.  Experience with biologics products is required.  Experience with viruses, gene therapy products or vaccines a plus.

Essential Duties and Responsibilities

Responsibilities include but are not limited to:

  • Manage QC organization within SillaJen, appropriate for a company moving into PIII and commercialization
  • Direct the validation of analytical methods to applicable global standards
  • Support the transfer of analytical methods
  • Help establish DS and DP specifications and ensure compliance with all relevant Pharmacopeias
  • Maintain oversight of precursor and reference standard CMO QC activities
  • Maintain effective QC-related cGMP documents
  • Design and implement study protocols, methods and comparability studies
  • Review and approve CMO and CTL plans, protocols and reports
  • Oversee the stability program and support studies for product handling at clinical sites
  • Prepare CMC documents pertinent to quality control for regulatory submissions

Education and Experience

  • Bachelor degree in scientific discipline or equivalent experience; advanced degree preferred
  • 10 plus years experience in quality control in the biopharmaceutical industry for biologics. With at least 5 years in QC   overseeing either viral, gene therapy or vaccine products preferred
  • Thorough knowledge of current cGMPs, ICH Quality guidance, FDA and EU CMC guidance
  • Thorough knowledge of industry-standard pharmaceutical QC methods and validation procedures
  • Ability to travel internationally to conduct audits as needed and interact with CTLs and CMOs worldwide
  • Excellent written and verbal communication skills

Specialized Skills

The Director QC must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, flexibility, a strong sense of responsibility, accountability, and integrity, including the ability to work proactively to resolve issues and to think “outside the box”.