Pharmaceutical Quality Control Manager

1 week ago

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

The Director of Global Quality Control Laboratory is responsible for overseeing 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
    • Design, develop, implement, and maintain 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.
    • Develop and maintain 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 with applicable Aquestive procedures, specifications, and compendia requirements.
    • Design and modify workflows accordingly to guarantee the highest quality of data and highest efficiency of resources.
  • Manage Direct Reports
    • Train, develop, coach, and evaluate direct reports to guarantee high-quality, high-technical integrity, and high productivity of work performed.
    • Demonstrate ability to foster concepts of teamwork, cooperation, self-control, and flexibility.
    • Set goals for direct reports and conduct performance reviews; manage the hiring process within the QC group and participate in candidate selection of applicable colleagues as necessary.
  • Provide Technical Expertise
  • Create and Implement Programs
  • Evaluate and Improve
  • Establish and Maintain Key Performance Metrics
  • Review and Evaluate
  • Canvas Global Industry Improvements
  • Continually Review and Improve
  • Author, Edit, and Review Technical Studies and Reports
  • Possess an Understanding of Budgeting, Staffing, Payroll, and Purchasing Processes
  • Lead Independent and Team-Based Investigations
  • Ensure a High Level of Internal and External Customer Support
  • Work Closely with Others in a Team Environment
  • Interpret Quality Control Philosophy
  • Maintain an Active Role in Driving Continuous Improvement Initiatives
  • Formulate, Document, and Maintain Quality Control Standards and Objectives
  • Coordinate Objectives with Production and Product Development Activities
  • Demonstrate Proficiency in Computer Use
  • Ensure Regulatory Compliance
  • Display Excellent Problem-Solving Ability
  • Interact with Internal and External Auditors
  • Assist in Performing Internal and External Audits
  • Manage Non-Routine Projects
Qualifications
  • BS/BA degree in a scientific discipline, advanced degree is a preferred.
  • 10+ years of laboratory experience with at least 5 years' experience in a pharmaceutical laboratory or regulated environment and 3-5 years of management experience.
  • Proven expertise in analytical skills, instrument techniques, and test method development.
  • Experience in test method validation.
  • Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
  • Highly motivated, self-directed, detail-oriented, with strong organizational skills.
  • Operates with a sense of urgency in a fast-paced environment.
  • Detail-oriented, quality-minded with excellent oral and written communication skills.
  • Proficiency in computer use (Word, Excel, PowerPoint, etc.), with ability to learn and master new computer applications.
  • Excellent technical writing skills.
  • Demonstrated knowledge and interpretation of cGMPs, regulatory guidelines, and regulatory documents such as CFRs; FDA guidance, EU guidelines, ICH guidelines.
  • Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner.
  • Experience in FDA and other regulatory audits.

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