• Director of Quality

    Astrix Technology (Anaheim, CA)


    Director of Quality

     

    Manufacturing

    Orange County, CA, US

    + Added - 08/05/2025

     

    Apply for Job

     

    The Director of Quality is responsible for leading the Quality Assurance, Quality Control, and Regulatory departments to ensure compliance with applicable regulatory standards, including cGMPs, FDA requirements, and internal quality systems.

    Job Title: Director of Quality

    **Location:** San Bernardino County, California

     

    Direct Hire

     

    Pay: $165,000 to 180,000 Annually

    Key Responsibilities

    + Develop and implement quality systems aligned with federal cGMP regulations for cosmetics and OTC drug products

    + Interpret and integrate regulatory requirements into manufacturing operations

    + Oversee creation and enforcement of quality policies, standards, SOPs, and strategic plans

    + Review and approve key documents including SOPs, product specs, BOMs, and validation records

    + Supervise the QA Supervisor, QC Manager, and Regulatory Manager, providing guidance and regular direction

    + Maintain and manage the customer complaint file, and ensure timely resolution

    + Lead internal quality audits and implement corrective/preventive actions

    + Respond to FDA observations and ensure full regulatory compliance

    + Maintain the OTC Master Drug List

    + Collaborate with suppliers, customers, and regulatory agencies on quality matters

    + Evaluate and approve supplier performance per established specifications

    + Measure performance against standards; drive continuous process improvements

    + Provide cross-functional training on customer and regulatory requirements

    + Attend external conferences and seminars to stay current on industry trends and regulations

    + Manage department budget and ensure cost-effective quality operations

    + Support all company policies and initiatives

    Required Qualifications

    + Bachelor’s degree in Biology, Microbiology, Chemistry, or Mathematics (Master’s degree preferred)

    + 10 years of experience in OTC drug manufacturing and quality

    + Minimum 5 years in a supervisory or management role in a regulated manufacturing environment

    + Strong knowledge of FDA regulations, cGMPs, validation, and quality system development

    + Proven experience with regulatory, third-party, and customer audits

    + Excellent organizational, problem-solving, and communication skills

    + Demonstrated leadership in people development, strategic planning, and cross-functional collaboration

    + Experience with manufacturing operations, technical documentation, and statistical analysisThis job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.