We are currently looking for a Head of Audit and Compliance
to join a global pharmaceutical company and work remotely
but be open to travel on a regular basis. The head office is based in the North West of England but you can work from home. As the Head of Compliance you will be responsible for supporting GxP and regulatory compliance of the products by developing audit systems to ensure process and product compliance are in line with GMP's throughout the product life cycle.
Duties and Responsibilities
- You will be responsible for supporting regulatory authority inspections internally and externally.
- You will develop audit systems to ensure key elements of the QMS and the requirements of the product licenses/ marketing authorisations are implemented throughout the internal and external manufacturing processes.
- You will lead GMP and GDP audits as well as maintain the audit master schedule and coordinate audit planning to ensure all stages of current products and supply chain, service providers and distribution networks are all being monitoring correctly.
- As the Head of Compliance you will lead, train and develop a team of quality and compliance specialists. You will also recruit when required.
- Supporting the quality groups and various other functions including, but not limited to, Regulatory affairs, business development, procurement will be among your duties.
- You will support the QMS Manager on audits and inspections of the QMS system.
Experience and education
- A degree or masters in a relevant scientific discipline such as Biology or Chemistry and a number of years of industry experience within the Pharmaceutical industry.
- At least 10 years of proven industry experience within a Pharmaceutical company is essential to your application as well as experience with sterile products.
- Proven experience hosting audits for FDA, MHRA, EMA is essential for this position.
- Excellent knowledge and experience of working with the FDA and EU GMPs understanding requirements for development, manufacturing and control and distribution of a commercial product is essential.
Pharmaceutical | FDA | MHRA | EMA | Auditing | Quality Assurance | Regulatory | Compliance | GMP | GDP | QMS | Quality Management | To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales