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Clinical Quality Assurance Consultant - GCP
700 Saginaw Drive Redwood City, CA 94043 US
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.
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Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
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Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
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Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
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Collaborate with internal stakeholders, internal or external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.
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Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.
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Provide support for Inspection Readiness activities.
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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.
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Escalate identified issues to QA Management as needed.
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Enable other assigned GCP or GXP-related tasks, as appropriate.
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Support GCP audits and inspections of, Vendors, and clinical investigator sites by regulatory authorities or business partners.
Required Skills, Experience and Education:
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Bachelor’s degree in a scientific or technical discipline.
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A minimum of 12 years of experience in GCP Quality in the pharmaceutical or biotechnology industry
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12 years in the following areas: audit/audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.
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Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (FDA, EMA) regarding applicable drug development regulations.
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Effective communication (verbal and written).
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Ability to build and sustain positive relationships with GxP colleagues, internal stakeholders, and external partners.
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Ability to critically evaluate and troubleshoot complex problems with diligence.
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Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
Preferred Skills:
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Good knowledge of Computer System Validation.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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