Quality Control Operations Manager

2 weeks ago

Portage, Indiana, United States Aquestive Therapeutics Full time

Position Overview:

The Quality Control Operations Manager is tasked with overseeing the Global Quality Control Laboratory to guarantee the integrity of processes and products while ensuring exceptional customer satisfaction through adherence to Good Laboratory Practices.

Key Responsibilities:

  • Oversee the operations of the Quality Control Laboratory.
    • Develop, implement, and sustain a comprehensive Training Program for laboratory staff.
    • Organize, assign, and supervise all laboratory activities, including Finished Product Release, In Process Release, Raw Material Release, and Stability Testing Release.
    • Coordinate efforts with external laboratories as necessary.
    • Establish and uphold efficient and compliant systems for sample management, testing, data analysis, instrumentation calibration, reference standard management, chemical inventory, data reporting, and documentation.
    • Ensure compliance with relevant company procedures, specifications, and regulatory requirements.
    • Adapt workflows to ensure the highest quality of data and optimal resource efficiency.
  • Lead and mentor direct reports through training, development, and performance evaluations to ensure high-quality and productive work output.
    • Encourage teamwork, cooperation, and adaptability among team members.
    • Set performance objectives for team members and conduct regular performance assessments; participate in the recruitment process for the QC team.
  • Provide technical guidance to both internal and external teams.
  • Design, document, and implement quality assurance programs, including the Stability Program, Environmental Monitoring Program, and Raw Material Testing Program.
  • Assess new methodologies, software, and equipment for laboratory use, ensuring quality in procurement.
  • Establish and monitor key performance indicators for laboratory operations.
  • Review and assess the effectiveness of company policies, procedures, and testing methodologies; identify areas for improvement and ensure resource adequacy.
  • Stay informed on global industry advancements and integrate relevant insights into company practices.
  • Continuously evaluate programs and systems to enhance efficiency, effectiveness, and quality.
  • Author and review technical documents, including studies, reports, protocols, specifications, and standard operating procedures.
  • Understand budgeting, staffing, payroll, and procurement processes.
    • Prepare budgetary forecasts and manage laboratory operations within allocated budgets.
    • Identify necessary resources to support quality control processes and communicate any proposed changes with supporting evidence.
  • Lead both independent and collaborative investigations.
    • Identify root causes for Out of Specification and atypical test results.
    • Develop and monitor corrective action plans.
    • Assist in customer complaint investigations as needed.
  • Ensure a high level of support for both internal and external customers.
  • Collaborate effectively within a team environment and contribute as a key member of multidisciplinary teams supporting Manufacturing and Product Development.
  • Communicate quality control philosophies to key stakeholders.
  • Actively participate in continuous improvement initiatives.
  • Formulate and maintain quality control standards and objectives.
  • Align objectives with production and product development efforts in collaboration with other managers to enhance product reliability and reduce costs.
  • Demonstrate proficiency in computer applications (Word, Excel, PowerPoint, etc.) and the ability to learn new software quickly.
  • Ensure compliance with regulatory requirements regarding documentation and record-keeping.
  • Exhibit strong problem-solving capabilities.
  • Engage with internal and external auditors.
  • Assist in conducting internal and external audits.
  • Manage special projects as required.

Qualifications:

  • Bachelor's degree in a scientific field; advanced degree preferred.
  • Over 10 years of laboratory experience, including a minimum of 5 years in a pharmaceutical or regulated environment and 3-5 years in a management role.
  • Demonstrated expertise in analytical techniques and test method development.
  • Experience in validating test methods.
  • Ability to manage multiple projects with competing priorities effectively.
  • Highly motivated, detail-oriented, and organized with strong time management skills.
  • Ability to work efficiently in a fast-paced environment.
  • Excellent communication skills, both verbal and written.
  • Proficient in computer applications, with a capacity to learn new technologies.
  • Strong technical writing abilities.
  • In-depth knowledge of cGMPs and regulatory guidelines.
  • Proven leadership skills that foster team confidence and motivation.
  • Experience with FDA and other regulatory audits.

The above description outlines the general nature and level of work expected from individuals in this role. It is not an exhaustive list of all responsibilities, duties, and skills required. The company reserves the right to modify the job description as necessary.

As part of the employment process, final candidates will be required to undergo a drug test and background check prior to starting employment. Please Note: The company maintains a drug-free workplace policy.

The organization is committed to providing equal employment opportunities and prohibits discrimination and harassment of any kind.

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