Manager, Quality Control

1 month ago

Portage, United States Aquestive Therapeutics Full time

Job Summary:

The Manager of Quality Control is responsible for directing the Global Quality Control Laboratory in order to ensure the overall quality of processes and products while maintaining the highest level of customer satisfaction, utilizing Good Laboratory Practices.

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 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.
    • 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 to internal teams as well as external partnered teams.
  • Create, document and implement programs, systems and procedures for monitoring and ensuring product quality such as the Stability Program, Environmental Monitoring Program, Raw Material Testing Program.
  • Evaluate new procedures and/or software and/or equipment for use within the laboratory.  Interact with vendors to ensure quality of any items purchased.
  • Establish and maintain key performance metrics for the laboratory.
  • Review and evaluate the effectiveness of company policies, procedures, specifications, test methodologies; identify and correct problems and assure the adequacy of resources.
  • Canvas global industry improvements, changes and forums, taking information back internally and applying to Aquestive.
  • Continually review 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.
  • Possess an understanding of budgeting, staffing, payroll and purchasing processes.
    • Prepare budgetary information and operate the laboratory duties within assigned budgets.
    • Determine necessary resources in order to support the operation and monitoring of quality control processes and communicate, provide supporting evidence for any proposed changes.
  • Lead independent and team-based investigations.
    • Determine root causes for Out of Specification and Atypical test results.
    • Develop, propose and monitor corrective actions.
    • Support customer complaint investigations as required.
  • Ensure a high level of internal and external customer support.
  • Work closely with others in a team environment and act 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.
  • Maintain active role in driving continuous improvement initiatives.
  • Formulate, document and maintain quality control standards and on-going quality control objectives.
  • Coordinate objectives with production and product development activities in cooperation with other managers to maximize product reliability and minimize costs.
  • Demonstrate proficiency in computer use (Word, Excel, PowerPoint etc.) 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.
  • Interact with internal and external auditors.
  • Assist in performing internal and external audits.
  • Manage non-routine projects as required.

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.

The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.

As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing.  Please Note:  Aquestive is a drug-free workplace and has a drug free workplace policy in place.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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