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    Quality Manager, AZ - Scottsdale, United States - Wedgewood

    Wedgewood
    Wedgewood Scottsdale, United States

    2 weeks ago

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    Description
    Job Details

    Level
    Management

    Job Location
    Scottsdale - Scottsdale, AZ

    Position Type
    Full Time

    Education Level
    4 Year Degree

    Job Category
    Pharmaceutical

    Description

    Great Care, DeliveredTM is the promise that we make to our customers. If you have a passion for helping animals, and a love for serving others - we want you to help us deliver on that promise by joining our Quality Team.

    The Quality Manager is responsible for implementing and managing site-level processes to monitor and control the quality performance of equipment, facility environment and systems, and personnel training and qualification to ensure continued conformance with the Company's quality and compliance policies. They will lead a quality culture that supports the Company's values of customer focus, integrity, and innovation through continuous collaboration with other functional areas. The Quality Manager effectively leads and manages direct reports and cross-functional teams to ensure achievement of established quality objectives while proactively identifying continuous improvement opportunities.

    When will you work?
    • This position works onsite in our Scottsdale, AZ office Monday - Friday.
    What you'll do:
    • Manages and/or executes viable and nonviable environmental monitoring, sanitary conditions audits, mechanical system monitoring (water systems, HVAC systems), and pest control monitoring.
    • Manages and/or executes initial qualification of equipment (IQ/OQ/PQ), ongoing calibration, validation, and requalification of equipment performance, and audits of equipment cleanliness.
    • Manages initial and on-going effectiveness verification of processes, equipment, and supplies associated with facility and equipment cleaning and/or disinfection.
    • Manages initial and on-going verification of sterilization processes, personnel, and equipment.
    • Manages processes for the initial and on-going verification/qualification of personnel.
    • Manages the processes for creating or modifying documentation and recordkeeping of any of the above functions, including Standard Operating Procedures.
    • Manages the execution of investigations into any nonconformances/OOSs associated with any of the above functions.
    • Determines and manages the execution of any immediate actions/control measures needed to mitigate quality or regulatory risk associated with nonconformances/OOSs associated with any of the above functions.
    • Approves any CAPA plans prior to plan execution, monitors the progress of in-process plan execution, and determines/documents when CAPA has been fully implemented.
    • Proactively identifies opportunities for improving quality, compliance, and efficiencies within the processes associated with the above functions.
    • Approves change control actions/plans and manages the execution of any quality or compliance-related steps within change control plans associated with any of the above functions.
    • Leads projects or initiatives associated with implementing changes to any of the above functions to meet Company regulatory policies.
    • Provides input to support the creation or alteration of Company quality and compliance policies.
    Who you are:
    • Have a strong understanding of compounding pharmacy principles including USP 795, 797, and 800.
    • Knowledge of cGMP relative to USP guidelines; 21CFR Parts 210 and 211, ICH guidelines, & FDA requirements for APIs and drugs
    • Possess excellent written, and verbal communication and presentation skills
    • Your analytical abilities coupled with creative problem-solving skills, is one of your key strengths
    • The ability to work in a dynamic, fast-paced and timeline-driven environment with shifting priorities excites you
    What you've done:
    • Obtained a bachelor's degree in a scientific/technical discipline
    • 7+ years' experience in compounding pharmacy and/or pharmaceutical manufacturing
    • 5+ years' working in progressively responsible positions in quality
    • 3+ years' experience managing staff and providing effective leadership to direct reports
    • Experienced in interfacing with regulatory agencies (e.g. State Boards of Pharmacy, DEA, and FDA)
    • Have prior experience working with both sterile and non-sterile compounded preparations
    What's in it for you:
    • A comprehensive benefits package that includes health, dental, vision and flexible spending accounts
    • 401(k) retirement plan with a generous company contribution to help you save for the future
    • Company Paid Life and disability insurance
    • Access to voluntary insurance options
    • A generous paid time off program that increases every year
    • Tuition reimbursement
    • Opportunity for growth - We believe in promoting from within and do so through our internal job posting program
    About Us

    Wedgewood is the nation's largest and most trusted provider of compounded veterinary medications. Its recent merger with Blue Rabbit enables the company to provide veterinarians with next-generation software to streamline patient care and marks a significant evolution in services. Together Blue Rabbit and Wedgewood serve more than 70,000 veterinary professionals and one million animals annually.

    Wedgewood is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. If you require an accommodation due to a special need or disability, please let your recruiter know what accommodations you will need.
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