Director, Quality Control

W2 only, no C2C, must be authorized to work in the US (both now and in the future).

Director, Quality Control (Direct Hire) - in Verona, Wisconsin. Apply now for this opportunity at Carex!

Carex is partnering with a Pharmaceuticals industry partner to find a Director of Quality Control to lead a comprehensive QC Laboratory operation—including analytical, microbial, stability, and reference standard testing functions. This leadership role will focus on developing and aligning laboratory operations, technical strategy, and compliance initiatives to meet business objectives. The position is based in Verona, WI and will play a key role in regulatory inspection readiness, technical oversight, and personnel development in a cGMP-regulated environment.

What You’ll Do

• Set the strategic vision for the Quality Control Laboratory, including planning, budgeting, and resource management aligned with organizational priorities.
• Direct and oversee QC activities in compliance with GMP regulations, including analytical method validation, raw material testing, and stability programs.
• Lead and develop QC staff, including hiring, coaching, and performance management across functional lab areas.
• Serve as the technical consultant for laboratory testing strategies and systems, ensuring alignment with business and regulatory requirements.
• Oversee the design and execution of multidisciplinary scientific projects, including preparation of project protocols, technical reports, SOPs, and other procedural documentation.
• Represent the QC function during internal and external audits, third-party inspections, and regulatory agency visits.
• Support the development of timelines, cost estimates, and contracts for projects in collaboration with internal stakeholders and external partners.
• Ensure continuous improvement of quality systems and laboratory workflows in line with evolving industry standards and business demands.
• Apply scientific expertise in the identification and characterization of oligonucleotides, polynucleotides, and raw materials.
• Collaborate cross-functionally to ensure timely execution of testing activities and overall operational efficiency.
  
  
  

What You’ll Bring

• Master’s degree in a scientific discipline required; Doctorate preferred.
• Minimum of 10 years of experience in a GxP-regulated pharmaceutical, biotech, contract manufacturing, or contract research environment.
• At least 5 years of experience directing QC laboratory operations in a cGMP facility.
• Deep knowledge of GMP, GDP, and relevant ICH/FDA guidance documents; familiarity with GLP and GCP regulations.
• Proven expertise in quality control systems, document control, and compliance in FDA-regulated environments.
• Strong leadership capabilities with demonstrated experience in team development and operational oversight.
• Experience with financial planning, budgeting, and cost management in a laboratory setting.
• Advanced proficiency in Microsoft Word and Excel.
• Willingness to travel occasionally for business needs.
• Strong business acumen with the ability to integrate scientific and operational objectives.
  
  
  

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.