Pharmaceutical Quality Control Manager

4 weeks ago

Portage, Indiana, United States Aquestive Therapeutics Full time
Job Summary:

Aquestive Therapeutics is seeking a highly skilled Pharmaceutical Quality Control Manager to lead our Global Quality Control Laboratory. As a key member of our team, you will be responsible for ensuring the overall quality of processes and products while maintaining the highest level of customer satisfaction, utilizing Good Laboratory Practices.

Key Responsibilities:
  • Direct Quality Control Laboratory Operations, including designing, developing, implementing, and maintaining the Training Program for laboratory personnel.
  • Plan, assign, and direct all work within the laboratory, including Finished Product Release, In Process Release, Raw Material Release, and Stability Testing Release.
  • Coordinate all work utilizing third-party laboratories, ensuring efficient and compliant programs for sample receipt and tracking, sample testing, data generation and analysis, instrumentation control and calibration, reference standard control, chemical inventory control, data reporting, documentation, and any other general laboratory system.
  • Ensure and enable completion of activities in compliance to applicable Aquestive procedures, specifications, and compendia requirements.
  • Design and modify workflows accordingly in order to guarantee highest quality of data and highest efficiency of resources.
  • Manage direct reports through training, development, coaching, and evaluation in order to guarantee high quality, high technical integrity, and high productivity of work performed.
  • Provide technical expertise to internal teams as well as external partnered teams, creating, documenting, and implementing programs, systems, and procedures for monitoring and ensuring product quality.
  • Evaluate new procedures and/or software and/or equipment for use within the laboratory, interacting with vendors to ensure quality of any items purchased.
  • Establish and maintain key performance metrics for the laboratory, reviewing and evaluating the effectiveness of company policies, procedures, specifications, test methodologies, identifying and correcting problems, and assuring the adequacy of resources.
  • Canvas global industry improvements, changes, and forums, taking information back internally and applying to Aquestive, continually reviewing programs and systems to develop and drive improvements in efficiency, effectiveness, and quality.
  • Author, edit, review, and approve technical studies and reports, protocols, specifications, and SOPs, possessing an understanding of budgeting, staffing, payroll, and purchasing processes.
  • Prepare budgetary information and operate the laboratory duties within assigned budgets, determining necessary resources in order to support the operation and monitoring of quality control processes and communicating, providing supporting evidence for any proposed changes.
  • Lead independent and team-based investigations, determining root causes for Out of Specification and Atypical test results, developing, proposing, and monitoring corrective actions, supporting customer complaint investigations as required.
  • Ensure a high level of internal and external customer support, working closely with others in a team environment and acting as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development activities.
  • Interpret quality control philosophy and communicate philosophy to key internal and external personnel, maintaining active role in driving continuous improvement initiatives, formulating, documenting, and maintaining quality control standards and ongoing quality control objectives.
  • Coordinate objectives with production and product development activities in cooperation with other managers to maximize product reliability and minimize costs, demonstrating proficiency in computer use, including ability to learn and master new computer applications.
  • Ensure regulatory compliance in maintenance of instrumentation records, test result documentation, usage logbooks, maintenance logbooks, and all other product or project-specific documentation with attention to accurate record keeping.
  • Display excellent problem-solving ability, interacting with internal and external auditors, assisting in performing internal and external audits, managing non-routine projects as required.

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