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GCP Quality Manager - Clinical QA

GCP Quality Manager - Clinical QA

Job Title: GCP Quality Manager - Clinical QA
Contract Type: Permanent
Location: Worthing
Industry:
Salary: Excellent Salary and Benefits
Start Date: 2019-08-26
Reference: J16330ST-1
Contact Name: Steve Twinley
Contact Email: steve.twinley@nextphaserecruitment.com
Job Published: August 27, 2019 07:34

Job Description

A brand-new position has been created for a Clinical Quality professional, with extensive knowledge of GCP and the implementation and development of quality systems. Are you keen to be part of an expanding Pharmaceutical organisation with genuinely amazing scientific concepts behind their drug products? If so, this role in Worthing, West Sussex (with travel to Europe and the USA) could be an ideal career move.
 
This permanent role has been created within one of Europe’s most innovative and unique Biopharmaceutical companies. We are looking for an energetic, visionary individual who can create systems and processes for the company to develop over the coming years, with their extensive pipeline of vaccine trials across Europe and the USA. You will be based in Worthing, West Sussex and will travel regularly to Germany and occasionally to America. Whether your background is more from Big Pharma or from smaller innovation businesses, if you have a deep understanding of Clinical QA (with a particular focus on early phase studies) we are keen to hear from you. The company is offering an excellent salary and benefits package, to be discussed on application.
 
The Company
 
A pioneering European-based Biopharmaceutical company specialising in the development and sterile production of injectable and oral dose vaccines and diagnostic kits for people who suffer from allergies. They have developed an innovative approach to medical treatments over a number of decades and are in an exciting phase of expansion across Europe and the USA. There are around 270 employees in total in Worthing, with a similarly-sized partner site in Germany; and the company has an excellent reputation for its welcoming atmosphere, staff morale and ongoing career development. They have a number of ongoing clinical trials in different countries and have created this new position in order to empower someone with responsibility for implementation and management of GCP quality systems.
 
The Role
 
Reporting to the Head of Corporate Compliance, you will develop, improve and maintain clinical quality management processes for the monitoring of the clinical research activities, including projects / studies in pre-clinical phase and clinical phases 1-4, and in accordance with all appropriate guidelines, regulations processes / protocols. 
 
Your role will include being the company interface for audits and inspections relating to GCP compliance, proactively anticipating changes to GCP legislation and their potential impact on the business. You will plan and monitor the quality of clinical study tasks, contributing to the vendor selection process by ensuring adequacy of vendor quality systems and standards. You will oversee clinical documentation processes, perform investigator site / vendor GCP audits, planning CAPA plans and follow-ups, and drive process improvement initiatives in support of the company’s forward-thinking approach to ongoing optimisation.
 
This is a broad and engaging role which requires a range of skills, as well as the willingness to travel to Germany, Spain, USA and other countries when needed. Full details, including a comprehensive job description, will be provided on application.
 
Benefits
 
In addition to a competitive salary (negotiable depending on experience), the company offers a very good benefits package including:
 
  • Annual bonus (discretionary and non-contractual)
  • Appropriate expenses for international travel (accommodation and travel costs)
  • Stakeholder pension plan
  • Life insurance scheme
  • 25 days’ holiday
  • Long term disability scheme
  • Private medical plan
 
Experience
 
The successful candidate will need to demonstrate very strong aptitude for Clinical Quality, including not only a strong background in GCP but also the pragmatic manner with which to introduce new processes. Candidates will be considered from large or small Pharma or CRO environments. The most important thing is that you can show adaptability, recognising that the company is not “Big Pharma” but is expanding rapidly and therefore needs to implement processes that it can “grow into”, with all stakeholders fully engaged with these processes. You must have the flexibility to be based primarily in Worthing, West Sussex, but spend extended periods (weeks or months) in Munich, Germany, as well as visiting other sites countries such as Spain and USA.