Quality Assurance (QA) Director

KBP BIOSCIENCES USA INC.

Job Title: Quality Assurance (QA) Director

Responsibilities:

  • The Quality Assurance (QA) Director will be responsible for providing oversight of the Quality Management System (QMS) and managing QA operation activities in accordance with Industrial standards, regulation, guidance, and other applicable laws, based on pharmaceutical development phases.
  • The QA Director provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities to company executive leadership team to ensure timely resolutions of the issues.
    The QA Director will cooperate with cross-functional stakeholders and support the compliance with Good Clinical Practice (GCP) standards, Good Manufacturing Practice( GMP) standards, and Good Laboratory Practice (GLP).
  • The QA Director will be responsible for leading and managing clinical QA operation to ensure that quality assurance initiatives and quality assurance plans are executed and maintained in full compliance with GCP requirements.
  • The QA Director will review and approve quality documents including but not limited to technical transfer reports, master batch records, and SOPs.
  • The QA Director will lead audits and manage health authority inspections.

Requirements:

  • Bachelor or above degree within pharmacy, biology or engineering and with at least 8 years’managerial experience in a production and/or quality function in the biotechnology / pharmaceutical industry.
  • ASQ Auditor certification, ASQ Quality Engineer certification preferred
  • Extensive working knowledge of quality system requirements such as US FDA GCP, GMP, GLP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements
  • Knowledge of fundamental quality engineering principles such as process validation, process capability, process control, and structured problem solving
  • Demonstrated ability to successfully interact with regulatory health authorities at inspections
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment • Proficient in MS Word, Excel, PowerPoint, Visio, Project, and statistical software