Associate Director/ Senior Manager, Quality Assurance (GCP)
Senior Manager/ Associate Director Quality Assurance (GCP) 1360908
Location: Greater Boston, MA (Remote)
Science/ Focus: Small Molecule
Job Overview: Lead the develop the clinical QA function by implementing a quality system that supports the compliance of ICH, GCP, GLP and other global regulatory requirements.
- Develop and implement risk management processes, and SOPs for internal and external oversight
- Oversee QA review and approval of clinical study reports, ICFs, external publications, and regulatory submissions
- Implement an early-stage clinical site quality audit program in collaboration with clinical study teams.
- Lead the nonclinical and clinical vendor, and internal quality audit programs.
- Ensure the nonclinical and clinical sites are audit ready and compliant
- Develop and conduct training
- BS/MS with 6+ years of experience in pharma/ biotech with significant experience in GCP
- Experienced with nonclinical and clinical studies including CRO oversight is ideal
- Previous exposure in GLP/GCLP is an added plus
- Able to travel as needed for audits
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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