We are working with an industry leading Healthcare Company who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.
Our client is seeking a Pre-Clinical Quality Assurance Manager near Boston, MA!
Our client is an industry leading international Pharmaceutical Company that manufactures drugs to treat/prevent a range of diseases and conditions. Innovation is a key element which has helped with tremendous breakthroughs with sickle cell disease as well as cancer. The client has sold their products in over 150 different countries across the world.
This position will support the Quality Operations and External Service Quality Team in the review of pre-clinical scientific studies. The Pre-clinical Quality Manager will be responsible for assessing the data integrity and good scientific principles of select externally conducted studies (GLP and non-regulated). In addition, they will support external audit/site visit activity, develop new processes related to post merger as well as acquisition integration activity.
- Must have experience with GLP and non-GxP clinical studies
- Review clinical data of external studies and assess the good scientific principals
- Conduct vendor audits as well as study reviews on a regular basis
- Analyze the endpoint movement of biomarkers to uphold quality standards
- Provide input to documentation and data storage systems
- Review and maintain up-to-date Standard Operating Procedures (SOP’s)
- Effectively report any quality issues to the supervisor/maintain GLP schedule
- Maintain appropriately detailed notes, audit reports and records
- Bachelor’s/Master’s degree in science, analytical field or pharmaceutical industry
- Minimum of three years in the pharmaceutical industry
- Must have research experience with an emphasis on Quality Assurance
- At least three years of experience in “hands-on” research in the life sciences industry
- The ability to manage multiple projects at the same time while working independently
- Excellent technical writing skills and the ability to manage data
- Strong analytical background and fluent in English (oral and written)
Qualified Candidates, Please Send us your CV
Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process