Quality Manager

Quality Manager - Pharmaceuticals

Location: London

Salary: to £35-40,000 plus attractive package

Quality manager - Pharmaceuticals

We are a well-respected and expanding medical information/ pharma company who provide both medical and pharmaceutical related services across three diverse business streams. Due to significant growth plans, we are employing a Quality Manager who will be responsible for managing and developing all aspects of the Quality Management System to the standards required by ICH, Good Clinical Practice (GCP), good pharmacovigilance practice (GPvP) and ISO 9001 and clients. The Quality Manager will be driving process improvement and compliance throughout the company and will lead a customer-focussed culture. Prior experience working for the MRHA is preferred and experience with Quality management and GCP is vital. The Quality Manager will be hosting client audits, regulatory inspections, and ISO 9001 assessments, and managing resulting action plans.

Quality Manager

Responsibilities:

• Identify and recommend quality improvements and use knowledge of best practices and internal or external business issues to develop, lead and drive their implementation
• Manage the corrective action / preventive action (CAPA) process
• Manage the review and writing of quality policies and procedures
• Monitor performance of the Quality Management System and report to the management team
• Work effectively across the company to maintain a state of readiness for regulatory authority inspections, ISO 9001 assessments and client audits
• Maintain as appropriate, relationships with MHRA and other regulators as needed

Qualifications and Experience:

• At least 5 years managing Quality Systems in a GCP or GxP regulated and an ISO 9001 compliant environment.
• Hosting regulatory inspections, ISO assessments and client audits
• Interacting with clients and customers
• Managing an internal audit programme A degree in biomedical or preclinical sciences; ideally with pharmacology or drug development at undergraduate or postgraduate level
• Qualifications in Quality Management and GCP, and a solid understanding of pharmacovigilance and drug safety
• Sound knowledge of ISO 9001
• At least 5-10 years in the biopharmaceutical industry in a similar position, managing Quality Systems in an environment regulated by GCP and ISO 9001 compliant
• Prior experience of working for the MHRA preferred.

When applying for this role, please indicate your current salary (plus benefits package), minimum salary required, notice period and your reasons for wishing to move from your current company. Alliance Consulting is acting as an employment agency in this respect. Alliance Consulting specialise in the placement of engineers throughout the UK. By sending us your CV you are explicitly consenting to our processing of your personal data on a computer database and/or in manual files for the purpose of evaluating your application for employment. This processing will be carried out in accordance with the UK Data Protection Act 1998. By applying for this role you hereby consent to us submitting your CV to our client. If you do not wish your CV to be sent to our client then you must clearly state this to us. Equally, if there are any companies that you do not wish your CV to be sent to (for whatever reason), then please let us know of this when you apply.