Quality Compliance Officer

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

To support growth, we are seeking a confident and proactive Quality Compliance Officer to join our Quality Assurance function within the Quality Compliance and Documents Team based in Weybridge. This role will ensure compliance functions are carried out in line with domestic license obligations.

Requirements

• Processing of MHRA import notifications and subsequent acknowledgements, inc. objections and further information requests.
• Processing HPRA exempt medicinal product notifications.
• Contribute to the management and review of NOI inventory planning levels in line with business and patient demand and in accordance with MHRA regulations.
• Ensure cover for all operational daily Quality Compliance duties in co-operation with colleagues.                                                                                                                                                                          
• Creation and maintenance of Quality Compliance ERP components.
• Internal and External processing of special clinical needs letters and in-house authorisations. 
• Participate in projects to implement new, or improve existing Quality Compliance processes.
• Support maintenance of team procedures.
• Preliminary horizon scanning of Quality/Regulatory websites and resources.
• Support business in resolution of item queries due to discrepancies.
• Develop and provide internal training related to Quality Compliance processes.

Benefits

• 27 days holiday plus 8 bank holidays
• Pension contributions 4.5% matched
• Life assurance 4 x annual salary
• Flexible Benefits Platform with £25/month Company contribution
• Annual salary review
• Independent financial advice service
• Enhanced Employee Assistance Programme
• Shopping discounts with retailers
• Long service awards
• Recognition scheme & employee of the year awards