Vice President Operations - Houston - Medix™

    Medix™
    Medix™ Houston

    1 day ago

    $150,000 - $320,000 (USD) per year * Pharmaceutical / Bio-tech
    Description

    Vice President of Operations

    Department: Pharmacy / Operations

    Reports To: President

    Position Summary

    The Vice President of Operations (VPO) provides executive leadership for pharmacy operations, sterile manufacturing, cleanroom expansion, and facilities development within a 503B outsourcing facility. This role is accountable for operational scalability, regulatory compliance, financial performance, and strategic growth.

    The VPO ensures full compliance with the U.S. Food and Drug Administration (FDA) and Current Good Manufacturing Practice (cGMP) requirements under the Drug Quality and Security Act (DQSA). This leader drives operational excellence across API sourcing through sterile compounding, while building the infrastructure, systems, and teams necessary to support expansion and long-term success.

    Essential Duties and Responsibilities

    Executive & Operational Leadership

    • Develop and execute a comprehensive operational strategy aligned with growth objectives.
    • Lead design, construction, and validation of cleanrooms and pharmacy production facilities.
    • Scale manufacturing capacity while maintaining sterility assurance and regulatory compliance.
    • Oversee pharmacy operations, facilities, procurement, supply chain, and production workflow integration.

  • Regulatory & Compliance Oversight (503B Experience Required)

    • Maintain inspection readiness and lead FDA regulatory inspections and audit responses.
    • Ensure adherence to cGMP, USP <797>, USP <800>, and applicable federal and state regulations.
    • Oversee licensure applications, renewals, and outsourcing facility registration requirements.
    • Establish robust operational controls that support quality systems and compliance initiatives.

    Process Development & Manufacturing Optimization

    • Design and optimize API-to-sterile compounding workflows within new and expanded cleanroom environments.
    • Implement production systems that improve efficiency, throughput, and quality metrics.
    • Collaborate cross-functionally with Quality, Regulatory, and Clinical leadership to ensure compliant product lifecycle management.

    Financial & Systems Management

    • Develop and manage operational budgets, capital expenditures, and multi-site project costs.
    • Monitor KPIs, production metrics, and financial performance to ensure profitability.
    • Lead implementation and optimization of ERP/CRM systems to enhance operational visibility and scalability.

    Leadership & Talent Development

    • Build, mentor, and lead high-performing pharmacy and operations teams.
    • Identify, train, and develop internal talent to support sterile compounding and manufacturing growth.
    • Foster a culture of accountability, compliance, collaboration, and continuous improvement.

    Education, Experience & Skills

    • Bachelor's degree required; MBA or advanced degree preferred.
    • 7–10+ years of progressive leadership experience in pharmaceutical manufacturing, biotech, or a 503B outsourcing facility.
    • Direct 503B experience required, including FDA audit and inspection leadership.
    • Demonstrated success scaling facilities, teams, and operational systems.
    • Strong financial acumen and capital project management experience.
    • Deep knowledge of sterile manufacturing, cleanroom environments, and cGMP compliance.
    • Exceptional strategic planning, problem-solving, and communication skills.
    • Entrepreneurial mindset with the ability to drive growth and transformation.

    Core Leadership Expectations

    • Operate with the highest standards of ethics and regulatory compliance.
    • Take ownership of outcomes, performance, and continuous improvement initiatives.
    • Lead with integrity, transparency, and respect.
    • Drive cross-functional collaboration to achieve strategic objectives.
    • Embrace change and foster a culture of innovation and accountability.

    Working Conditions

    • Work performed in office, cleanroom, and laboratory environments.
    • Must meet gowning and cleanroom entry requirements.
    • Prolonged periods of sitting, standing, and computer work required.
    • Ability to lift up to 50 pounds.
    • Moderate noise levels in production environments.
    * This salary range is an estimation made by beBee
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