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Alabaster

    Head of Quality - Alabaster, United States - Croda Singapore

    Croda Singapore
    Croda Singapore Alabaster, United States

    2 weeks ago

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    Description


    Croda's Avanti business has been at the forefrontof Lipid Technology innovation for over 50 years and has gained internationalsuccesses through our partnership with leading pharmaceutical developers as wecontinue to lead the market in polar lipid innovation.

    Following Croda's acquisition of the Avantibusiness in 2020, we have been focused on integrating and globalising businessand are now looking to recruit an experienced Head of Quality to lead the QA & QC department consisting of two direct reports and a total of 70 people across the site.

    We're therefore looking for an exceptional peopleleader who can create and implement a site quality strategy to support ourambitious growth plans whilst driving a cultural transformation within Avanti'squality organisation.


    Whowe're looking for:


    Msc / PhD qualified with prior experience in a Senior Quality role within a cGMP API manufacturing, CDMO and/or research organisation with strong knowledge of FDA regulations.

    Excellent understanding of Quality Standards such as ISO9001, EXCiPACT & EU GMP and quality requirements throughout clinical development phases.
    Strong track record of developing a robust and matured quality culture within a global, matrix driven organisation
    Proven people leader who is able to build inclusive and diverse teams, with a background in creating and sustaining high-performance working cultures
    Experienced in leading change management and cultural transformation activities

    A passion for continuous improvement with a high level of curiosity and ability to challenge the status quo to drive efficiency and innovation in the quality function.

    Quality Auditing qualification and experience is highly desirable

    KeyResponsibilities

    Manage overall budget and performance of the QC and QA departments whilst capturing and promoting continuous improvement opportunities across the function.

    Be an active member of the site senior management team and the global Croda Pharma Quality and Regulatory leadership team.

    Effectively plan and organize short- and long-term projects ranging from process improvements to capital planning
    Continually develop Quality Management Systems to ensure compliance with regulation and group standards and overall business strategy
    Provide a technical support service to other departments as required including customer inquiries and complaints

    Interpret legislation and undertake detailed investigations with multiple immediate and root causes to develop action plans to improve the quality function.

    Effectively communicate and influence people at all levels within Croda and with Quality regulators
    Own and host the site's Quality Management Review process.

    Crodarecognizes employees as our strength and the diversity they bring to ourworkforce are directly linked to our ongoing success. We are an equalopportunity employer and place a high value on diversity and inclusion at ourcompany.

    We do not discriminate on the basis of any protected attribute,including age, race, color, religion, national origin, gender, sexualorientation, gender identity, gender expression, marital or veteran status,pregnancy or disability, or any other basis protected under applicable law.

    Inaccordance with applicable law, we make reasonable accommodations forapplicants' and employees' religious practices and beliefs, as well as anymental health or physical disability needs.

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