Clinical QA (GCP) Consultant - Contract - Remote US
Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.
À±½·ÊÓƵ is seeking a Clinical QA (GCP) Consultant to support global clinical quality assurance activities on a contract basis. The position is remote, with a preference for candidates who can occasionally visit the New Providence, NJ office if local. This is a part-time role, anticipated 24 hours per week, with flexibility in duration (approximately 4-5 months).
Primary Responsibilities:
The successful candidate will focus on ensuring compliance with GCP standards, regulatory requirements, and internal SOPs for clinical trials.
Skills & Requirements:
- Bachelor's degree in life sciences or a related field (advanced degree preferred).
- Experience in GCP Quality Assurance within the pharmaceutical, biotech, or CRO industry.
- Proficiency in conducting GCP audits (sites, vendors, systems).
- Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA).
- Excellent interpersonal, communication, and documentation skills.
- Ability to work independently and collaboratively in a matrix environment.
- Detail-oriented with strong organizational skills to manage multiple priorities effectively.
The Clinical QA (GCP) Consultant's responsibilities will be:
- Manage quality issues and escalate as necessary.
- Provide input on CAPAs related to GCP compliance.
- Plan, execute, and report GCP audits, including site, vendor, and electronic system audits.
- Develop, revise, and maintain Clinical Quality Assurance SOPs and Work Instructions.
- Collaborate with cross-functional teams (e.g., Clinical Operations, Regulatory, Pharmacovigilance) to address quality concerns.
- Support inspection readiness and assist during regulatory inspections.
- Escalate significant quality findings to QA management and recommend corrective actions.
- Participate in continuous improvement initiatives to strengthen the quality culture.
- Perform additional tasks as assigned by management.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.
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