Associate Director, Quality Control

Location:
SC

Position Id:
20817

Associate Director, Quality Control

My client is a mid-sized biopharmaceutical organization on the fast-track to great product success. They are seeking an Associate Director of Quality Control with pharmaceutical experience and management/mentoring expertise for their Southeast location. They have doubled in size over the last 3 years and are projecting more exponential growth and to go public in the coming year.

Requirements:

  • BS Chemistry or related field (Master’s preferred)
  • Minimum of 6 to 8 years in Analytical Quality within a GMP environment
  • Extensive experience with QC Validations, Method Transfer, Stability requirements, CFR 21 and ICH guidelines
  • Strong strategic, problem-solving and management skills
  • Data-driven decision-making and interfacing with stakeholders
  • Experience in laboratory techniques, instrumentation and QC activities (HPLC-UV, GCMS, KF, & IC)

Responsibilities:

  • Provide guidance and strategic direction to managers and staff in QC department
  • Oversee all QC activities and reporting
  • Ensure quality and integrity of analytical testing are compliant and efficient
  • Assist with regulatory inspections
  • Promote continuous improvement and train accordingly

This is a great time to join this organization. If qualified and interested, please submit your resume. This a great growth opportunity with a competitive salary.

Keywords: Chemistry, Validation, Stability, HPLC, GC, GMP, FDA, Quality, Quality Assurance, PAI preparation, audits, Quality Ops, CFR 21, ICH, pharmaceutical, manufacturing, QC, Quality Control, Mentor, Train, KF

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