Quality Assurance Manager
We are working with an industry leading CRO 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 Quality Assurance Manager in Cleveland, Ohio!
Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment. This position will develop, manufacture and characterize small molecule drug substances while complying with GLP/GMP regulations. The manager will provide oversight for the company’s quality standards and systems, making improvements when appropriate.
Specific Responsibilities:
- Review/Approve quality documentation (batch records, project protocols, validation plans, quality agreements and associated analytical data)
- Responsible for reviewing/approving deviations, the post-investigative report and the corrective/preventative actions to implement going forward
- Conduct regular audits to ensure all compliance and standards are met
- Responsible for enforcing Good Manufacturing Practices (GMP) and supplier/material qualification
- Manage study data related to the company’s quality standards
- Monitor change control, deviations, and CAPAs through the QMS database
- Responsible for three to five direct reports
- Responsible for archives, document control and implementing a training program
- Manage inspections by regulatory governing bodies (FDA/EMA)
Qualifications:
- BS in a technical field or a minimum of 7-10 years of experience of in the pharmaceutical/ biotech industry
- Five or more years in QA manufacturing and small molecule characterization
- Knowledge of drug development process
- Familiarity with data integrity and qualifying equipment
- Experience managing multiple priorities and quality assurance staff
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.
