Senior Manager, Clinical Quality Assurance (GCP)
Proclinical have partnered with this exciting medium-sized, fully integrated Pharmaceutical company that develop and manufacture their own products in Oncology, Neurology and CNS. They have an excellent culture and have one of the most exciting pipelines in the industry.
Reporting into the Director of Clinical Quality Assurance you will be responsible for Quality oversight activities for this company's clinical trials, systems and vendors. You will be leading audits as well as taking full responsibility for hosting and managing the Health Authority Inspection strategy ensuring inspection readiness at all times. This role is truly cross-functional involving management of internal and external stakeholders and leading Quality Improvement initiatives across the company. High-visibility role with huge impact across the business with a chance to worked autonomously as well as collaboratively.
Required Skills Experience:
You will need to be educated to at least Bachelor's degree level and have demonstrable experience in a Clinical Quality Assurance setting within a Pharmaceutical or Biotech environment. You will have thorough knowledge of Clinical Operations and fundamental knowledge of the US, EU and international regulatory standards that they must adhere to. You will have extensive experience of planning and carrying out routine, complex and for-cause GCP audits as well as ideally having Inspection Management/Readiness experience..
In return they are offering a highly-competitive salary and benefits package as well as an environment that will uniquely challenge you with the infrastructure to develop you professionally.
This will be office-based in Hatfield but with flexibility to work from home if neccessary.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.