Head of Quality Control

The Head of Quality Control ensures products meet corporate standards as well as all applicable government regulations. Oversees all aspects of an organization’s quality control function. Being a Head of Quality Control requires a bachelor’s degree. Develops procedures for testing of final product and makes decisions regarding the issuance of recall notices. In addition, Head of Quality Control typically reports to top management. The Head of Quality Control manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head.

Head of Quality Control Job Description Template

Our company is looking for a Head of Quality Control to join our team.

Responsibilities:

  • Develop plan for the qualification of the new QC laboratory as well as organization of the QC laboratory equipment;
  • Partner with Product Quality and Regulatory to support CMC deliverables;
  • Participation in risk assessments;
  • Ensure product testing is appropriately completed (most assays are cell-based (e.g., flow cytometry, PCR, cellular imaging, etc.);
  • Ensure that adequate personnel are available to perform the QC functions;
  • Perform instrument and method qualification (method qualification will be phase appropriate);
  • Implement key performance metrics to monitor process health and assist with prioritization of improvement activities;
  • Lead the QC team;
  • Write, review, and approve validation protocols and reports;
  • Support investigational new drug (IND) chemistry-manufacturing-control (CMC) section writing;
  • Ensure that out of specifications and deviations are appropriately investigated and resolved;
  • Support Annual Product Review (APR) and Annual Report (AR) activities;
  • Provide technical support for site and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections );
  • Work collaboratively with M anufacturing, QA and QC to ensure timely suupport of issues;
  • Participating in cross-functional collaborations to meet project timelines and material supply requirements.

Requirements:

  • Comprehensive knowledge of current Good Manufacturing Practices ( cGMPs ) and multi-national regulations;
  • 1 0 years of experience in team leadership roles overseeing organization and staff development;
  • Experience with analytical method development , validation and transfer a s well as product characterization and analytical comparability;
  • Bachelor of Science with at 15 years of relevant experience in biotechnology/pharmaceutical industry;
  • Ability to travel up to 20% of the time;
  • Ability to effectively prioritize and deliver high-quality results on tight timelines;
  • Experience in managing and leading small teams within proscribed timelines and budgets;
  • Strong leadership skills and ability to effectively communicate up, down and across the organization;
  • Experience with setting up and developing an entire QC lab is a plus;
  • Previous experience in QC experience is required. Experience with cell therapy is preferred;
  • Excellent communication skills, both written and oral, and high degree of organization in terms of goal setting and achieving;
  • Self-starter with demonstrated ability to deliver high-quality results in a fast-paced development environment;
  • Outstanding problem – solving skills including the ability to devise and implement practical solutions to resolve complex issues;
  • Excellent written and verbal communication and presentation skills;
  • Experience in development, optimization, validation, execution, and troubleshooting of cell-based bioassays.