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QA Director

Cranleigh Scientific
Job LocationCambridge
EducationNot Mentioned
Salary£90,000 - £100,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

A global biotech company has an exciting opportunity for a QA Director to join its team. You will lead the Quality team, to implement a fit for purpose Quality Management Framework to support the Corporate goal of creating a quality-driven culture. You will be joining a growing team and must have a hands-on, collaborative approach to your work. You will be an experienced quality professional with significant experience gained within the biotechnology industry.Location: Cambridge, UKPrimary Function and Purpose:

  • Lead the small molecule Quality team, to implement a fit for purpose Quality Management Framework (QMS) to support the Corporate goal of creating a quality-driven culture.
  • Adapt, develop and expand the QMS from the current cGMP framework to cover all GXP regulations, especially, GLP, GCP and GPvP, create and manage the quality management plan compliant with regulatory requirements whilst aiming for streamlined quality-focused workflows.
  • Implement and maintain a robust Quality Management System which assures that the business processes are reliable, safe and compliant to all GxP requirements and established requirements.
    • Key responsibilities
    1. Ensure that the quality assurance plan supports the corporate strategy in alignment with regulations and standards.
    2. Develop and implement a highly effective quality assurance plan that fully addresses quality assurance and controls, that enables the corporate goals of producing high-quality and safe pharmaceuticals.
    3. Ensure the implementation and the maintenance of standard procedures describing quality systems required for GXP compliance such as but not limited to the following systems: Clinical study conduct, Clinical IMPs release and labelling, Patient Safety oversight and delivery, Change Management, Deviation and Investigation of quality incidents and Vendor CMOs/CROs, CAPA program, Training program, Documentation control.
    4. Develop and implement a Quality plan that addresses routine QA oversight and responds to the demands of the business and drives a culture of continuous improvement
    5. Ensure that all business processes (including CMO/CRO oversight) and quality operations are performed in compliance with GXP requirements, including activities performed by third party vendors and associated partners.
    6. Ensure that all third-party vendors are validated prior to initiating work that will be supportive of a regulatory submission to ensure they can deliver to the quality demanded by the organization
    7. Oversee the release of clinical trial supplies and prepare for commercial manufactured products release
    8. Prepare, coordinate and host regulatory inspections at site(s) and ensure timely follow-up on inspection observations responses closure.
    9. Foster collaboration and partnership with the functional leads in R&D, Medical, Clinical Operations, Regulatory and CMC development to ensure all groups work together to develop a corporate culture of quality to maintain compliance and achieve business goals.
    Experience Required:The ideal candidate will have:
  • A Bachelors or more advanced degree in biochemistry, chemical engineering or related scientific discipline;
  • Significant QA/QC experience in across the GXP disciplines within the biotechnology industry, with a minimum of 8 years of managerial experience in a quality capacity
  • Developed and executed a clinical quality framework to ISO certification standard
  • Ensured the appropriate governance framework is implemented to allow for rapid and appropriate decision-making
  • Experience of working to GLP, GCP and GPvP
  • Developed a risk based QMS
  • A pragmatic and solution focussed approach
  • The ability to work in a small company environment and take a hands-on approach as required
  • Managed 3rd party providers
    • Required skills
  • Biotech - GxP - GMP - GCP - Quality Assurance

    • Keyskills :
    Biotech - GxP - GMP - GCP - Quality Assurance

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