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GCP Quality Assurance
2 months ago
Location: Cambridge, MA (Hybrid)
Science: Microbiome
Job Overview: This role will oversee compliance and quality processes for clinical trials, managing relationships with CROs, Investigator Sites, and stakeholders.
Primary Job Responsibilities:
- Develop and maintain GCP Quality Systems and SOPs.
- Provide expert guidance on GCP regulations and requirements.
- Resolve QA and compliance issues to keep projects on track.
- Partner with Clinical Operations to build a risk-based QA system..
Primary Job Requirements:
- Preferred: Bachelor's or higher in clinical/medical science, professional certifications a plus
- Required: 6+ years of experience with Sponsors, CROs, or GCP consulting.
- Valued: Experience with Regulatory Authority GCP and BIMO Inspections; continual growth in relevant GxP areas.
About Stratacuity:
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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