This is a permanent role.
Bath ASU produces over 3,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need of pain relief. Through our scientific and technological capabilities, the team continuously develops new and innovative methods to improve our products and services.
On offer is an unrivalled opportunity to join a successful, rapidly expanding company with a great team spirit. Due to early retirement, we are looking to recruit the position of Head of Quality Unit to support the continued delivery of an exceptional service. This would be a great opportunity for an individual who has at least 10 years’ experience working within Quality in a regulated cGMP environment who is experienced in leading and managing a significant Quality Unit function. You will work with the team to continue to develop our capacity and capability so that we can continue to deliver our products to hospitals and patients homes across the UK and beyond.
Who we’re looking for
The successful candidate should be a member of Royal Society of Chemistry/ Royal Society of Biology/ RPS (or eligible) with commitment to CPD and should have a Post Graduate Quality Assurance qualification and/or equivalent. An EU Qualified Person/QP or QP IMP is sought but an exceptional candidate who can quickly achieve QP status with full company support will be considered.
The overall job purpose is:
- Driving the Quality Strategy to ensure compliance with regulatory expectations in accordance with EU Guidance on Good Manufacturing Practice.
- Managing and deployment of the Quality department resources, currently a team of 20, to ensure both effective operational performance and maintain appropriate standards of cGMP compliance.
- Leading the governance of the QMS and GMP compliance to manage risks and highlight key challenges
- Actively pursuing opportunities for quality improvement and promote a strong culture of Quality awareness within the organisation
- Operating as a key member of the leadership team to establish collective priorities and remove barriers to progress
- Managing the preparation, execution and follow through of GMP/ IMP Regulatory Inspections
- Taking the lead in communicating with the MHRA on the ‘Specials’, IMP and Veterinary Licences.
- Hosting and managing audits and inspections by clients as required as part of regulatory affairs
In return we offer rewards and benefits including:
- Competitive Salary (dependent on experience, knowledge and skill set)
- Bonus and Incentive Plan
- 21 days holiday, increasing to 26 days with service
- Life Insurance
- Pension scheme
- Company Car, Laptop and Phone
- Additional non-contractual benefits including onsite free breakfast and fruit, and outdoor gym
Nestled in the heart of the West Country with easy access to the World Heritage City of Bath, and with great transport links to London and private education you can experience an unparalleled quality of life in a company that also has a zero carbon status. This is a fantastic opportunity to join a growing business which is well placed to capitalise on its successful track record to date.
Commit to excellence. Join our team “Where patients come first”. If you would like more information about this position or would like to apply with covering letter and CV, please email email@example.com
Closing date for applications is – 14th October 2018. Initial interviews will take place on 25th October 2018. You will be contacted by the 18th October 2018 if you have been shortlisted for the initial interviews.