Director of Clinical Quality Assurance – 22-124
Fully Remote
Description

The Director of Clinical Quality Assurance oversees the Quality Assurance department and ensures the strategic plans and objectives of the department are met. The QA department is responsible for ensuring that the drug manufacturing and clinical trial processes comply with all applicable government regulations and cGxP standards so that the drugs manufactured by Elevar meet our standards and that clinical trials produce accurate and credible results. This position is responsible for developing, implementing, maintaining, and improving the corporate quality assurance system and has oversight to all cGxP activities. Champions continuous improvement efforts to establish an effective Quality Management System (QMS). This position provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements. This is a remote-based position. 

Requirements
  •  Responsible for oversight for Elevar’s products and ensuring Elevar’s compliance objectives are maintained and updated to meet overall organizational needs.
  • Assures quality products and processes by establishing and enforcing quality standards and regulatory requirements.
  • Directs the activities of the quality assurance staff by recruiting, selecting, orienting, and training employees.
  • Encourages employee engagement and results through delegation, continuous feedback,
  • goal setting, and performance reviews.
  • Ensures that the QMS is reflective and appropriate for Elevar’s changing and expanding roles and responsibilities as a drug manufacturer and in non-clinical and clinical research. o Initiates and implements quality improvement activities as appropriate to raise the performance of the company.
  • Writes and updates quality assurance procedures.
  • Ensures that employees receive required GXP training and education.
  • Interacts with suppliers to identify opportunities to improve quality and monitor performance.
  • Interfaces with supplier quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
  • Reports to management on quality issues and trends.
  • Track record of business performance improvement.
  • Experience hosting FDA and other regulatory authority audits.
  • Experience conducting supplier audits and internal audits.

 

Requirements:

  • Bachelor’s degree in science, engineering or business discipline or equivalent number of years of experience.
  • Ten years of experience in QA systems implementation and management.
  • Five years of experience in a QA leadership position
  • Firsthand experience of audits by regulatory authorities.
  • Working knowledge of quality system requirements
  • Demonstrated track record and success in team building skills and people management and leadership.
  • Track record of business performance improvement.
  • Experience hosting FDA and other regulatory authority audits.
  • Experience conducting supplier audits and internal audits.