Quality Operations Manager

Job Details

A Global Pharmaceutical company are presently looking to bring in a highly experienced Quality Operations Manager to be based either the South London Office.

Purpose :
To co-ordinate, lead and Manage the provision of a Quality Assurance service to the UK business, primarily Consumer Healthcare and Nutritional Business.
A management representative with the responsibility and authority for ensuring that that the appropriate quality standards and systems are implemented and maintained for the operation of the UK operations.

Accountabilities

To represent the UK business in all internal links to the Quality Organisation.
*To communicate and integrate relevant Quality Systems into the UK business operations.
Liaison with warehousing/distribution management to ensure that change of status instructions for products shipped under quarantine is correctly managed.
*Monitor quarantine product movement and provide status control.
Function as Responsible Person for distribution on all quality related issues
*Assist with quality management of third party contractors (manufacturers, contract packers, testing laboratories, licensees, co marketers, impulse sales) in conjunction with Contract Operations QA
To carry out (may be delegated as needed) the following Quality related activities:-
*To provide a final check and GMP review of product artwork.
*To act as the UK Quality Assurance approver of all third party Technical Agreements and Quality Agreements.
In conjunction with UK Regulatory Affairs Departments to ensure that the Wholesale Dealers and Wholesale Dealers Import Licences are up to date.
To represent UK in terms of quality management and to be the business contact for communication of quality issues.
*Act as the primary point of contact for quality defects, customer complaints related to product and device defects, product returns management, communications to Regulatory Authorities (including decisions on recall) and reviews by the Area Quality group
*Where necessary create and maintain appropriate local operating procedures e.g., recall, customer complaints, control of quarantine goods
*Provide QA input to projects and concepts.
*Provide management and follow -up services for local authority inspections
To manage and support the administrative release of PCH & Nutri products received from the manufacturing network via day to day functional coordination with Quality Executives.
To oversee the customer complaints of products received and liaise with Quality Executives and business partners
Contribute to the professional development of Quality Executives
To advise Head of Quality Operations on the allocated budget, including contributing to the development of annual proposals for funding of the Product Quality function

Experience
*Eligible as a Responsible Person under directive 2001/83EC or Qualified Person, under Directive 2004/27/EC and 2004/28/EC.
*Graduate (a scientific or technical degree is preferred).
*Manufacturing experience preferable.
*Understanding of local business needs
*Excellent written and verbal communication skills.
*A demonstrated ability to effectively influence colleagues at all levels of an organisation.
*Good team worker, with leadership experience including strong skills in planning and prioritising.
*Demonstrated continual development in both technical knowledge and industry regulations.

Are you available or interested?
To Apply:

To apply, please click on the Apply button. Ideally, please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Luke Webber on +44 (0) 207 440 0635 or upload your CV on our website. Full description available on request.

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Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.