Head of Quality Assurance - Pharmaceutical

Industry Sector Pharmaceutical
Profession QA & Regulatory
Location UK, South East
Salary Competitive

Description

Head of Quality Assurance - Pharmaceutical 

Oxfordshire

Salary - DOE

Full Time, Permanent

 

The Company

Our client is a worldwide Pharmaceutical CRO working on drug discovery and development projects for major Pharma and Biotech businesses. Due to continued company success an opportunity has become available for a key position within their Oxfordshire facility.

 

The Role

The Head of Quality Assurance is a senior role within the Quality Unit department reporting to the Head of Global Drug Development Quality Unit. The role will be an essential part of the QA team to guarantee GMP compliance aspects related to company business.

 

Duties/Responsibilities

·       Leadership of the UK Quality Assurance (QA) Department

·       Driving Quality Assurance with Continuous Improvement techniques throughout the organisation

·       Ensure global QA policies and initiatives are implemented at the Oxford site

·       Ensure QA personnel are trained and knowledgeable to perform their assigned job description

·       Ensure all activities within the QA department are in line with company policy, and is cGMP compliant at all times

·       Monitor Quality KPIs for the site and provide trends to Site Quality Council (SQC) and relevant corporate management

·       Drive improvements in site KPI’s from adverse trends reported in SQC

·       Consult all departments to ensure their compliance to company policy, best practice and cGMP

·       Lead initiatives to drive improvements in the standards of cGMP and quality culture across the sites

·       Produce results in line with company policy, best practice and cGMP in the desired timeframes as directed by the business and by their line manager

·       Leading change and risk management activities for Quality

·       Quality Assurance Representative within the UK Site Leadership

 

Suitable applicants will be able to demonstrate the following competencies

·       A willingness and ability to consistently perform all Quality Leadership tasks

·       A confident ability to take decisions in a timely and reasonable manner

·       Have consistency in the project results generated

·       The ability to inspire trust and confidence from key internal and external stakeholders from routine performance

·       An excellent awareness of cGMP procedures and API Manufacturing, within both the QA Department and other areas of the business

·       The ability to lead the Quality Assurance division independently and with gravitas

·       Have excellent time management and organisational skills

·       Communicates clearly across all departments to resolve any Quality related issues

·       Perform cGMP and Quality related intra- and inter-departmental training and on-boarding of new staff members across site

 

Qualifications/Experience

 

·       A thorough and extensive knowledge of cGMP, API Manufacturing and other Regulatory requirements

·       Significant industry experience within a Senior Quality position within the Pharmaceutical sector

·       Experience hosting MHRA, FDA and other regulatory/health authority inspections

·       Strong Leadership skills

·       Dynamic with a vision for success

·       Have a in depth understanding of QA processes and requirements in a commercial environment

·       Display resourcefulness, innovation and initiative

·       Must be self-motivated and dynamic with the ability to manage project budgets, schedules and have excellent communication skills with clients, suppliers and internal departments

·       Clear Investigational skills

 

If you meet the above criteria the apply now for a further discussion about your skills and experience.

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