The Director of Quality  is responsible for managing pharmaceutical quality assurance and quality control programs, and reporting to the VP of Quality Assurance. The Director of Quality will manage all quality programs and continuous improvement as it relates to global internal operations and collaborative processes with external vendors. This position requires knowledge of GLP and GMP regulations (both US and international) and inspection preparations, depending on areas of responsibility. The Director of Quality will manage a quality team of 40, so should have experience leading a QA and QC team of significant size.  This position will require domestic and international travel.

We are seeking quality directors who are career-driven, have strong leadership skills, and a depth of experience in driving successful pharmaceutical quality assurance and quality control teams.  We offer accelerated career growth potential and excellent benefits. We have many opportunities and consider only the best candidates to join our highly talented quality group.

typical roles and responsibilities for Director Quality

  • Develop and implement programs to improve internal quality
  • Manage a large quality team, including QA and QC
  • Foster continuous improvement efforts and culture
  • Develop and manage quality department budget
  • Define department goals and metrics
  • Manage CAPA program
  • Manage department contract negotiation and review for vendors and contract staff
  • Manage Quality System, including quality metrics reporting
  • Chair quality management review meetings

Requirements for the Director of Quality

  • Bachelor’s degree in chemistry, organic chemistry, biochemistry, or a relevant scientific discipline; advanced degree preferred
  • 10+ years of QA experience in the pharmaceutical industry or a combination of pharmaceutical and other related FDA/EU regulated industry
  • Progressive management experience in pharmaceutical quality, ultimately leading a quality team of significant size
  • ASQ certification preferred
  • Six Sigma
  • GCP and GMP QA experience
  • Experience with a range of dosage forms, including solid dosage, liquid sterile, and lyophilized product
  • A depth of FDA facing experience in managing both internal audits and external audits
  • Strong management skills with the ability to drive competency and deliver information at all levels within an organization
  • Strong communications skills; oral, written, electronic and presentation
  • A track record of accomplishment in managing multiple competing priorities on tight timelines

Salary range for Director Quality

  • $150,000
  • $160,000
  • $170,000
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