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    QA Director

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    Ahmed Azzam
    The QA Director is responsible for leading quality operations to ensure compliance with regulations and the release of clinical and commercial products. This includes implementing quality policies, communicating with regulatory agencies, auditing suppliers and service providers, and reporting on quality performance. The ideal candidate has 10+ years of experience in biotechnology and manufacturing, an advanced degree in life sciences, knowledge of EU and FDA guidelines, and strong communication and leadership skills.

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    QA Director

    Uploaded by

    Ahmed Azzam
    10 views2 pages
    The QA Director is responsible for leading quality operations to ensure compliance with regulations and the release of clinical and commercial products. This includes implementing quality policies, communicating with regulatory agencies, auditing suppliers and service providers, and reporting on quality performance. The ideal candidate has 10+ years of experience in biotechnology and manufacturing, an advanced degree in life sciences, knowledge of EU and FDA guidelines, and strong communication and leadership skills.

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    The QA Director is responsible for leading quality operations to ensure compliance with regulations and the release of clinical and commercial products. This includes implementing quality policies, communicating with regulatory agencies, auditing suppliers and service providers, and reporting on quality performance. The ideal candidate has 10+ years of experience in biotechnology and manufacturing, an advanced degree in life sciences, knowledge of EU and FDA guidelines, and strong communication and leadership skills.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    10 views2 pages

    QA Director

    Uploaded by

    Ahmed Azzam
    The QA Director is responsible for leading quality operations to ensure compliance with regulations and the release of clinical and commercial products. This includes implementing quality policies, communicating with regulatory agencies, auditing suppliers and service providers, and reporting on quality performance. The ideal candidate has 10+ years of experience in biotechnology and manufacturing, an advanced degree in life sciences, knowledge of EU and FDA guidelines, and strong communication and leadership skills.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    QA Director - Halix

    QA Director
    The QA director is leading the quality operations to ensure compliance with
    EU and FDA directives and is ultimately responsible for the release of clinical
    trial materials or commercial batches. The QA director will represent and
    communicate the quality policies and performance to authority bodies,
    customers and business partners and ensure corresponding alignment in the
    company.

    Tasks and Responsibilities


    • Performance of the quality operations consisting of QP’s, quality assurance
    and quality control teams.
    • Implementation of quality policies in project management, development,
    manufacturing and quality operations.
    • Relationship and communication with Dutch inspectorate IGJ/Farmatec in
    order to maintain and update GMP permits and manufacturing licenses.
    • Audit readiness and manage GMP inspections performed by Dutch
    inspectorate or FDA authorities.
    • Good relationship and communication with customers in order to negotiate
    quality agreements, perform audits or solve quality challenges.
    • Periodic reporting of the quality performance using key performance
    parameters, in line with EU/FDA quality directives and including improvement
    planning.
    • External auditing at service providers and suppliers as part of the vendor
    rating system.
    • Service complaints or product quality complaints.

    Requirements
    • Academic degree in life sciences (e.g. pharmacy, immunology, virology).
    • 10 years of experience with biotechnology and CMC manufacturing.
    • Experience with biotechnological production on clinical and industrial scale.
    • Broad knowledge and experience with EU/FDA GMP guidelines and
    inspections.

    Personal & Professional Skills


    • Natural authority.
    • Being able to apply situational leadership.
    • Experience with communication on all levels including with officials and Sr.
    management.
    • Good knowledge of English, both verbal and written. Dutch advantageous.
    • Decisive, analytical and accurate.
    • Ability to be creative, thinking out of the box.

    Offer
    • We offer you a highly dynamic job in an interesting environment
    • You will be working from our headquarters in Leiden, where the products are
    produced on site.
    • HALIX offers great benefits including a competitive salary and contribution to
    pension and health insurance.

    Recruitment Consultant Felipe van Gerwen


    [email protected]
    020 – 700 8888 / 06 – 51066744

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