Job#: 2044624
Job Description:
GCP Quality Assurance 2044624Location: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..
- Preferred: Bachelors 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.
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.
PROVEN SCIENTIFIC PLACEMENT
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EEO Employer
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Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
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