UK Quality & Regulatory Manager role based in Basingstoke with a company providing Global solutions in an entrepreneurial and innovative way.
We're looking for someone to cover maternity leave for 1 year, who has the ability to analyze and use data to drive forward process improvements. They will also have experience in taking part in the management of the regulatory audit process, as well as being able to interpret and apply the relevant domestic and international regulations and industry standards.
As this is a complex role, we have included part of the job specification below:-
Accountable for the maintenance and compliance of the Quality Management System with applicable requirements (ISO standard, Corporate requirements, Regulatory compliance, etc.) in order to ensure that customer expectations are met. Supports and supervise the process owners to ensure the implementation and continuous improvement of the QMS. Contributes to the Corporate and Northern Europe Cluster organisation.
Main Accountabilities :
Quality/Environmental Management System Representative
" Responsible for the implementation of the corporate quality policy. Responsible for the definition and implementation of quality objectives and relevant Key Process Indicators for the subsidiary. Contributes to Corporate and Cluster quality objectives.
" Identifies quality training needs, defines quality training plan and ensures appropriate quality training of local staff, including Quality and Environmental Inductions
" Accountable and responsible for document and record control, including the distribution of Corporate quality documents and the implementation of the resulting applicable requirements.
" Accountable to manage and execute critical supplier audits, external audits, and internal audits to ensure inspection readiness, with support of internal auditors. Accountable and responsible for the execution of the Management reviews and outputs, Change Management, CAPA and Supplier approval processes for the subsidiary - including assuring the continued supplier qualification.
" Accountable to ensure that an effective complaint handling process is in place. Accountable and responsible to manage customer satisfaction surveys as required.
Regulatory Compliance Representative
" Accountable and responsible to monitor the local regulatory environment.
" Responsible for vigilance (adverse events reporting), reporting to authorities, and communication with authorities, customers, third parties regarding quality.
" Manage the implementation of Field Corrective Actions (FCA/FSCA/MAR/PSS/PRS).working with and providing support to the Customer Service team for action to be implemented in the field.
" Ensure reporting in a timely manner to the Competent Authorities, and ensure Trackwise is up to date on adverse events reporting.
" Second vigilance back-up for Nordics
Typical Studies-Experience, Skills and Qualifications:
o Bachelor of Science Degree in organisation, quality, science or relevant area. Masters' degree preferred,
o Preferably 5 years of Quality Management, Quality control, Internal auditing, (to govern knowledge in internal organization or activities) in or Regulatory Affairs experience including QMS project management.
Excellent Microsoft office knowledge with documented experience
" Skills and Qualifications:
o Excellent verbal and written communication skills; ability to motivate and lead projects within all levels of the organization.
o Ability to analyze and use data to drive process improvements.
o Experience in participation in the management of regulatory audits (i.e. ISO 9001, ISO 14001, , FDA, EPA, , etc.);
o Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
In return -
A salary of £36- 38 K
Group protection income
Group Life Insurance
Private medical Insurance (after 6 months )
Company Gym membership
Shopping discount programme
Bonus scheme pro rata