Director of Quality Control - Charlottesville - Afton Scientific, LLC

    Afton Scientific, LLC
    Afton Scientific, LLC Charlottesville

    1 week ago

    Description

    At Afton Scientific, every role contributes to advancing the quality and reliability of sterile pharmaceutical manufacturing. Our team is driven by innovation, collaboration, and a commitment to excellence. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

    We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking a Quality Control Director to support our growing biopharmaceutical operations at our on-site facility in Charlottesville, Virginia.

    Overview of this Position

    The Director of Quality Control is responsible for the strategic oversight and day‑to‑day leadership of all QC laboratory operations supporting sterile injectable pharmaceutical manufacturing. This includes analytical testing, environmental monitoring, stability programs, investigations, and laboratory compliance. This is a hands‑on director‑level role in a growing organization. The individual in this position must be comfortable owning decisions, building scalable systems, leading teams through change, and representing QC with regulators, clients, and internal stakeholders.

    Non-Negotiable Requirements


    •Minimum of eight (8) years of progressive experience in Quality Control within a GMP‑regulated pharmaceutical, biopharmaceutical, or CDMO environment


    •Minimum of four (4) years of experience leading QC teams and laboratory operations (Manager‑level leadership or above)


    •Minimum of four (4) years of hands‑on experience supporting FDA inspections, regulatory audits, and client audits


    •Strong working knowledge of:

    • cGMP requirements applicable to QC laboratories
    • OOS/OOT investigations and CAPA processes
    • Data integrity principles (ALCOA+)

    Preferred Requirements


    • Bachelor's degree in chemistry, Biology, Life Sciences, or a related scientific discipline


    •Experience in a CDMO or contract manufacturing environment


    •Prior experience with sterile or aseptic manufacturing and injectable products


    •Familiarity with LIMS and laboratory digital systems


    •Experience supporting tech transfers, scale‑up, or new product introductions


    •Advanced degree (master's or PhD) in a scientific discipline


    •Experience operating in a growth or transformation environment (scale‑up, expansion, new facility)

    Responsibilities Include


    •Lead and oversee all Quality Control operations, including:

    • Analytical and in‑process testing
    • Environmental monitoring and trending
    • Stability programs
    • Release testing and laboratory scheduling


    •Ensure QC operations meet or exceed cGMP, FDA, and regulatory expectations


    •Serve as the primary QC representative during regulatory inspections, audits, and client interactions


    •Own and drive QC‑related investigations, including OOS/OOT events, deviations, and CAPAs


    •Partner closely with Quality Assurance, Manufacturing, Technical Operations, and Engineering to support compliant, efficient production


    •Build, develop, and retain a high‑performing QC team, including managers, supervisors, and analysts


    •Establish clear ownership, accountability, and escalation pathways within the QC function


    •Ensure laboratories are properly staffed, trained, equipped, and validated to support current and future business needs


    •Drive continuous improvement initiatives while maintaining data integrity and compliance


    •Support implementation and optimization of laboratory systems and workflows as the organization scales

    Reasonable accommodation language and disability statement retained as in original text, without formatting emphasis.


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