Senior Manager, GxP Quality
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Hobson Prior are looking for a Senior GxP Quality Manager to join a top pharmaceutical organisation on a permanent basis in East London. Our client concentrates on delivering transformative medicines to enable people living with rare chronic diseases live a better life.
Ensure the implementation and continuing compliance to the client's comprehensive quality and compliance systems, associated procedures, standards and local regulations.
Provide leadership and resource management support.
Ensure that Policies, Worldwide Quality Standards Operating Procedures are implemented in accordance with US, EMA, other international and local GXP and PV guidelines.
Manage and perform self-inspections and internal auditing to assess site compliance on a regular basis.
Safeguard the business by staying fully informed of new or emerging GxP GMP/GDP and regulatory changes in the relevant region.
Manage the review and implementation of Quality Improvement/remediation plans identified through Corporate as well as internal GxP audits.
Working alongside the Corporate Quality organization, acting as the Quality liaison for GDP/GXP/PV, consider and communicate any quality and compliance risks.
Monitor GDP, GXP and Pharmacovigilance compliance.
Act as the primary Responsible Person and ensure that the provisions of the licence are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01).
Strong capacity for leadership.
Exceptional communication and interpersonal skills.
Ability to work in a dynamic environment.
Capability to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
Excellent planning and organisational skills.
Significant experience with computerized system for Change Control, Deviation and CAPA management.
Proven previous experience with Quality Assurance/Compliance and management in the pharmaceutical/biotech industry.
Eligible to act as the named Responsible Person.
Detailed knowledge of relevent local and global regulatory requirements required for GDP, GXP compliance.
Familiarity with government regulations, laws and guidelines relating to GXP and Pharmacovigilance.
Knowledge of pharmacovigilance AE reporting systems and regulations.
Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
Bachelor's Degree in physical/life science or pharmacy.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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