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Director Quality Control

4 weeks ago

Baltimore MD United States EPM Scientific Full time

We have a current opportunity for a Director Quality Control (Maryland) on a permanent basis. The position will be based in Baltimore County with a growing pharmaceutical manufacturing organization

Responsibilities:

  • Oversee daily operations and personnel in the Quality Control (QC) Laboratory.
  • Develop and implement strategic plans for the department and staff.
  • Manage laboratory activities independently, including timelines and work plans for projects.
  • Motivate and coach QC staff to achieve goals and improve their skills.
  • Support other departments (like QA and RA) with investigations and compliance activities.
  • Collaborate with R&D, QA, Business Development, and Manufacturing teams on project coordination.
  • Assist in formulation development and transfer activities for projects.
  • Evaluate and improve analytical methods and procedures.
  • Prepare and review technical documents, such as validation protocols and analytical reports.
  • Provide training and technical support to laboratory staff.
  • Standardize laboratory processes and ensure compliance with regulations and best practices.
  • Maintain equipment qualifications and oversee preventative maintenance.
  • Audit laboratory data and recommend new equipment as needed.
  • Ensure departmental objectives are met.
  • Perform additional duties as required.

Qualifications:

  • Bachelor's degree or equivalent experience in analytical chemistry or a related field.
  • 10+ years of experience in analytical chemistry and quality control in the pharmaceutical industry.
  • Familiarity with modern analytical instruments and their maintenance.
  • Strong problem-solving and leadership skills.
  • Experience managing technical issues and mentoring staff.
  • Proficient in writing technical documents and reports.
  • Knowledge of federal and international regulations in pharmaceuticals.
  • Familiar with electronic Quality Management Systems (e.g., MasterControl, Trackwise).
  • Proficient in Microsoft Office tools (Word, Excel, PowerPoint, etc.).
  • Strong communication skills and ability to work under pressure.
  • Results-driven, organized, and able to manage diverse teams and projects.