Job Title : Associate Director, GCP Quality Assurance
Summary : Looking for an opportunity to work with cutting edge oncology technology? Are you someone who is interested in taking on a challenge and being a part of a company with technology that is targeting a variety of different therapeutic areas including oncology, CNS and cardiovascular? My client is a leading biopharmaceutical company with over 30 products across 80 countries worldwide, including China, Europe, Japan and the US. They are currently developing antibody and biosimilar products and are looking to add a talented GCP Quality leader to their team. If you are looking to become part of a team that is breaking down walls in numerous therapeutic areas, this may be the role for you!
The Associate Director, GCP Quality Assurance will be responsible for :
- Overall Quality Assurance of Global Clinical Development Program.
- Guiding, interpreting and informing on GCP/GLP regulations, standards and quality systems to other functional areas.
- Develop and implement SOP's, standards, policies and procedures for GCP/GLP regulatory compliance.
- Plan and lead GCP/GLP audits including clinical investigator site, contract clinical laboratories and CRO's.
- Conduct QA reviews of project related Clinical Development essentials (protocols, amendments, case report forms, table and listings, etc.)
- Facilitate GCP/GLP training and develop appropriate training personnel.
The Associate Director, GCP Quality Assurance should have the following requirements :
- Bachelor's Degree in a Life Sciences or technical discipline.
- At least 10 years and FDA/EU regulated environment.
- Ability to accurately interpret and apply regulatory expectations for a robust and compliant GCP.
- Ability to build and establish internal and external relationships in a highly dynamic environment.
- Strong organizational, leadership and team building skills.
If this sounds like something you would be interested in, please apply!
