Group Quality & Regulatory Affairs Director Jobs – Oxfordshire

Flame Pharma Exclusive
Group Quality & Regulatory Affairs Director Jobs – Oxfordshire
Strategic appointment reporting to the CEO. Excellent salary
Flame Pharma is working alongside an international diagnostic and testing organisation in recruiting the Group Quality and Regulatory Affairs Director for their offices in Oxford. This strategic role will oversee and direct the quality assurance, quality control and regulatory affairs functions with responsibility for 3 sites and 5 divisions
The Role
As Group Quality & Regulatory Affairs Director your role will involve the following:
• Formulate and direct the development and implementation of goals, objectives, policies, procedures and systems of all quality and regulatory compliance for all group companies.
• Develop corporate regulatory strategies. Oversee preparation of documentation for worldwide regulatory government submissions.
• Develop validation strategies for the organisation
• Through subordinate managers, manage the effectiveness of the quality assurance, quality control and regulatory functions.
• Assure effectiveness of departments through appropriate resourcing, scheduling, training, prioritization, and contingency planning.
• Create, review and approve budgets and short/long term plans.
•  Participant in site leadership team meetings to ensure continued focus in quality and regulatory affairs matters.
• Communicate business strategy and objectives to subordinates to ensure the quality and regulatory affairs group are supporting business and quality objectives as required.
The Person
As Group Quality & Regulatory Affairs Director you will have the following skills and experiences:
• Strong technical knowledge and expertise to critically evaluate QC test results and QA investigations to assess product quality impact.
• Thorough knowledge of cGMP compliance requirements related to the validation, manufacture, testing, and release of products commercially supplied to the US, EU and international markets.
• Direct hands-on interactions with FDA and other regulatory agencies.
• Bachelor’s degree in a scientific field plus 15 years directly related progressively more responsible experience in Quality and Regulatory Affairs.
• Previous experience in a medical device company.
• Strong technical expertise in in-vitro diagnostics.
If you feel you have the essential skills and experience for this role please contact Flame Pharma on 0800 085 0858 or email your CV to [email protected]