Associate Director, GCP Quality Assurance
Princeton, New Jersey
A leading international biotechnology company is seeking an Associate Director GCP Quality Assurance to join its rapidly expanding team! With a global presence, this company specializes in the invention and development of differentiated human antibody therapeutics.
If you're looking for the step up in your career and have the drive to move forward, then apply for the position of Associate Director, GCP Quality Assurance
The Associate Director, GCP Quality Assurance will have the following responsibilities:
- Be an active QA GCP representative in both the early and late-phase clinical development, including oversight of global GCP compliance
- Conduct Quality Audits within GCP and relevant regulated areas, internally and externally, and perform vendor evaluations.
- Provide internal QA support in the organization
- Handle and participate in GCP inspections performed by national and regulatory authorities
- Handle Clinical Quality Agreements
- Participate in the development and maintenance of the existing Quality Management System (QMS) and associated GCP SOPs
- Participate in training and education of employees in GCP, and other relevant guidelines and regulations
The ideal candidate will have:
- MSc in Pharmacy/health science or a related scientific degree or are alternatively otherwise medically trained.
- 5-10 years relevant industry experience in GCP and/or areas working in a Clinical or Quality department.
- Experience in oncology/haematology first-in-human trials and/or late phase and trained auditor.
- Experience working in an EDMS system, such as Veeva Vault document management system, including deviation and CAPA handling. Experience in SOP and GCP training is also beneficial.
- A good sense of humor is beneficial.
Does this sound like you? Apply today!