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    Director of Quality - New York, United States - LHH

    LHH
    LHH New York, United States

    1 week ago

    LHH background
    Description


    LHH Recruitment Solutions is hiring The Quality Director oversees the leadership and management of quality systems and processes across the organization, including their development, implementation, maintenance, and evaluation.

    They ensure the company adheres to quality standards established by regulatory agencies, ISO9001:2015, compendia such as USP, and customer specifications.

    Additionally, this role ensures that quality practices align with relevant standards, regulations, and procedures.


    Duties:


    Develop and deploy quality assurance and quality control policies, procedures, and objectives to ensure alignment with customer requirements, relevant regulatory standards, and ISO criteria.

    Lead, oversee, and nurture the Quality Assurance/Quality Control teams.

    Cultivate a comprehensive understanding of products and processes to effectively analyze and interpret customer issues, facilitating the implementation of corrective actions and enhancements to processes or products.

    Keep abreast of regulatory requirements and updates, ensuring the company's compliance with local, national, and international regulations.
    Encourage ongoing improvement initiatives.
    Define goals and metrics for the QA department.
    Chair quality management review meetings.
    Analyze and communicate quality metrics, trends, and performance to the CEO, Board of Directors, and Senior Leadership Team.
    Cultivate and sustain relationships with customers, vendors, and regulatory bodies to ensure adherence to standards.
    Collaborate with Procurement to monitor supplier performance and establish, implement, and maintain supplier auditing processes.
    Supervise the implementation of the DQ/IQ/OQ/PQ process for new process or equipment implementation projects.
    Collaborate with Marketing to regularly review and update customer-facing product technical information as needed.

    Work with HR to assess suitable staffing levels for the department, conduct performance evaluations, and provide mentorship and coaching to enhance the team's knowledge, skills, and abilities.

    Create and execute quality training programs tailored for both management and hourly employees.
    Other duties assigned



    Requirements:
    Bachelors Degree or higher in Engineering or a related scientific field, required
    At least 15+ years of Quality Management experience in biotech, pharma, or a disinfectant manufacturing environment

    Ensure compliance with International, Federal, State, and local regulations, including FDA regulations, cGMP standards, and ISO standards such as ISO 9001, ISO 17025, ISO 11137, ISO 13485, and ISO 14001.

    Lead successful process improvement initiatives using continuous improvement methodologies and root cause analysis.
    Utilize proven leadership skills to mentor, develop, and enhance the knowledge, skills, and abilities of QA/QC departments.
    Exhibit strong project management skills, including task prioritization, meeting deadlines, and managing multiple projects concurrently.
    Have experience with contamination control principles


    Nice to have:
    Preferably hold Six Sigma Black Belt or Green Belt certification.
    Prefer familiarity with EPA and/or BPR regulations for disinfectant products.
    Ideally, possess experience with microbiology and environmental monitoring of controlled classified areas.
    Experience with cleanrooms and aseptic processing
    Textile industry experience

    Physical

    Requirements:
    Utilize testing equipment and handle products manually; operate computers.
    Engage in frequent standing, walking, sitting, and reaching with hands and arms.
    Occasionally lift and move objects weighing up to 25 lbs.
    Occasionally perform tasks such as climbing, balancing, stooping, crouching, crawling, and smelling.
    Maintain visual acuity including close, peripheral, and depth perception vision.
    Work in a moderately noisy environment.
    Occasionally work in a warehouse environment without controlled temperature.
    Reasonable accommodations will be provided for individuals with disabilities to perform essential job functions.
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