Stratacuity
GCP Quality Assurance
Stratacuity, Cambridge, Massachusetts, us, 02140
Location:
Cambridge, MA (Hybrid)Science:
MicrobiomeJob 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 plusRequired: 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.PROVEN SCIENTIFIC PLACEMENTStratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Cambridge, MA (Hybrid)Science:
MicrobiomeJob 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 plusRequired: 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.PROVEN SCIENTIFIC PLACEMENTStratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.