Senior Manager, GxP Quality

Employer
Hobson Prior
Location
England, London
Salary
£60000.00 - £65000.00 per annum
Closing date
29 Sep 2020
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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.


Job Responsibilities:

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).

Key Skills:

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.

Requirements:

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.

Apply now:

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.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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