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Clinical Quality Assurance Consultant - GCP

Redwood City, CA 94043

Posted: 10/09/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 615135 Is job remote?: Yes Country: United States

Job Description


The Opportunity:   Clinical Quality Assurance Consultant - GCP

Seeking a contractor, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing compliance support for sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

  • Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.

  • Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.

  • Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

  • Collaborate with internal stakeholders, internal or external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.

  • Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.

  • Provide support for Inspection Readiness activities.

  • Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, root cause analysis, CAPA planning and management.

  • Escalate identified issues to QA Management as needed.

  • Enable other assigned GCP or GXP-related tasks, as appropriate.

  • Support GCP audits and inspections of, Vendors, and clinical investigator sites by regulatory authorities or business partners.

Required Skills, Experience and Education:

  • Bachelor’s degree in a scientific or technical discipline.

  • A minimum of 12 years of experience in GCP Quality in the pharmaceutical or biotechnology industry

  • 12 years in the following areas: audit/audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.

  • Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (FDA, EMA) regarding applicable drug development regulations.

  • Effective communication (verbal and written).

  • Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.

  • Ability to critically evaluate and troubleshoot complex problems with diligence.

  • Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

  • Good knowledge of Computer System Validation.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Redwood City, CA

Ready to embark on an exciting career opportunity in the vibrant area around Redwood City, California? Nestled in the heart of Silicon Valley, this thriving region offers a perfect blend of innovation, growth, and charm. From the bustling tech scene to the serene beauty of Redwood City's parks, like Edgewood Park and Pulgas Ridge Preserve, there's something here for everyone. Immerse yourself in the local culture by visiting the Fox Theatre or exploring art galleries like The Art Center and Redwood City Art Kiosk. With a bustling food scene offering everything from trendy cafes to authentic Mexican cuisine, it's no wonder that Redwood City is a top choice for job seekers looking to thrive in a dynamic environment. Browse our job listings today and take the next step towards a fulfilling career in this captivating locale!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.