Working for a leading pharmaceutical company, we are seeking a Quality Manager to join the team. The ideal candidate will be an experienced Quality Manager with a GMP/ Manufacturing background. This role will have 2 direct reports so team leadership skills are required along with knowledge of pharmaceutical regulations.
- Acts as the principal or deputy Quality Business Partner for the assigned Business Unit.
- Manages complex Quality issues and influences across matrix reporting organisations to evidence resolution in a timely manner to the benefit of patient and business needs.
- Assures compliance and provides cross-departmental support for the assigned Business Unit Operations, Regulatory, Supply Chain, Customer Services, Pharmacovigilance and Scientific Information, to meet business requirements whilst ensuring compliance with GxP requirements and Corporate Quality Standards.
- Is responsible for organising the management of the training of personnel within internal departments on GxP requirements that impact upon their activities.
- Is the lead in auditing of GMP, GDP and GxP Service Providers to ensure they meet both Company and Regulatory expectations for the services provided.
- Manages the maintenance and improvement of the assigned Quality MCO processes in line with Regulatory Authority requirements and Corporate Quality Standards, including the Quality Event/Deviations and Change Control systems.
- Works cross functionally to minimise disruption to product supply and support the timely release to market of product that is in compliance with the licensed particulars.
- A degree or professional qualification in Science, preferably a Life Science and significant related industry experience in Quality or Medical / Regulatory Affairs.
- Significant experience and knowledge of quality systems within pharmaceutical industry typically achieved over a number of years in more than one position.
- Proven managerial and technical experience with the Quality Environment.
- Awareness of ABPI Code of Practice.
- Understands principles, concepts, practice and standards for Pharmacovigilance and Scientific Information.
- Familiar with the pharmaceutical research and development process, and capable of critically reviewing and integrating scientific information from a variety of disciplines.
- Auditor qualification is desirable - Experience in managing GxP audits / inspections. Ability to lead in audits, key participant in regulatory inspections and follow up.
- Company Bonus
- 25 days Annual leave + Bank Holidays
- Private Medical Insurance
- Private Dental Cover
- Life Assurance
- Critical Illness Cover
- Childcare Vouchers
- Share Incentive Plan