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    Director of Quality - Lexington, United States - Kindeva Drug Delivery

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    Description

    Job Summary:

    The Director of Quality will be in charge of all quality assurance and control processes at Kindeva Drug Delivery/Summit Biosciences in Lexington, Kentucky. This position involves managing and enhancing the company's quality standards while ensuring compliance with regulatory requirements. Reporting directly to the Vice President of Operations, the Director of Quality will collaborate with various teams to drive continuous improvement and maintain high levels of customer satisfaction.

    Compensation & Benefits:

    • Competitive salary and benefits package
    • Opportunities for professional growth and development
    • Collaborative and dynamic work environment

    Responsibilities:

    • Developing and implementing quality control procedures and standards for regulatory compliance and customer specifications
    • Leading and managing Quality Assurance and Quality Control teams for efficient operations
    • Overseeing and enhancing the company's Quality Management System
    • Conducting internal audits and ensuring prompt resolution of non-conformances
    • Acting as the primary interface with regulatory agencies during audits
    • Collaborating with teams to identify and implement process improvements
    • Providing regular reports to the Vice President of Operations on quality objectives
    • Developing relationships with suppliers for quality materials
    • Delivering training programs for adherence to quality standards

    Requirements:

    • Bachelor's degree in Life Sciences, Engineering, or related field
    • Minimum 10 years' experience in quality management within pharmaceutical or medical device industry
    • Knowledge of FDA regulations, ISO standards, and Good Manufacturing Practices (GMP)
    • Proven team management experience
    • Strong problem-solving and decision-making skills
    • Excellent communication and interpersonal skills
    • Ability to work effectively in a fast-paced environment
    • Attention to detail and effective task prioritization
    • Proficiency in Microsoft Office and Quality Management Systems software

    EEOC Statement:

    Kindeva Drug Delivery/Summit Biosciences emphasizes equal opportunities for all applicants, irrespective of race, religion, sex, or national origin, ensuring a fair hiring process based on qualifications and skills.



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