A rapidly growing immuno-oncology based organization is looking to add to their incredible team! With the development of a potentially first-in-class oral dosage drug which addresses a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies, this bioscience organization is absolutely booming! While establishing a fun, innovative, and inviting culture, this companies dedication to advancing novel medicines for people with cancer speaks volumes!
- Maintain establish and develop the QA procedures to ensure Good Documentations Practices in a GxP environment.
- Understand global regulatory agency policies and guidance as they pertain phase appropriate Gxp Compliance.
- Manages document control, training, and audit programs. .
- Develop/Review/Approve Quality Documents, and Review/Approve eQMS related implementation documentation.
- Oversee CRO's to optimizing processes and ensure high quality data outputs.
- Manage PO's and work with finance team to communicate accruals and financial forecasts related to translational work.
- Ensure Documents and procedures comply with all external and internal guidelines.
- BS with at least 5 years of experience in Pharma and QA
- Experience with implementations of eQMS solutions.
- Ability to manage multiple projects in a fast-paced environment, project management experience a plus.
- Working knowledge of relevant FDA, EU, MHRA, ICH guidelines and regulations.
- Knowledge of late-stage pharmaceutical development and validation principles
- Excellent judgment and ability to communicate complex issues in an understandable way.
- Great communication skills
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.