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This role requires candidates who are currently authorized to work in the U.S. without sponsorship, and C2C arrangements are not accepted. EST hours are required.
The GCP Operational Sr Quality Project Manager is responsible for overseeing and managing quality assurance activities related to clinical trial operations to ensure compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, study protocols, and internal policies and procedures. The role includes developing and executing study-level audit plans, identifying and mitigating compliance risks, monitoring quality issues and compliance metrics, managing investigations and CAPAs, and ensuring inspection readiness.
Key Responsibilities:
- Serve as the Quality Lead for assigned clinical programs, providing GCP compliance interpretation, consultation, and support to maintain and improve research quality while ensuring the protection of subjects’ safety, rights, and well-being, as well as the integrity and credibility of generated data.
- Maintain up-to-date knowledge of industry trends, standards, and methodologies related to GCP.
- Collaborate with internal clinical functions and external stakeholders, including CROs, vendors, and investigator sites, to promote high levels of quality and consistency across programs.
- Provide QA review of study protocols and participate in operational review boards to identify and mitigate operational risks.
- Develop and implement risk-based audit plans for assigned programs, ensuring audits are conducted according to plan, reviewing audit reports, and overseeing CAPA plans in line with company standards.
- Lead and/or manage domestic and international audits of clinical investigators to ensure compliance with ICH GCP, applicable regulations, and company policies.
- Oversee quality issue investigations, perform root cause analyses, and assist study teams in developing and implementing CAPAs to support sustainable compliance.
- Contribute to continuous quality improvement initiatives and engage with study teams to ensure proactive inspection readiness.
- Provide support for regulatory inspections at company facilities or clinical investigator sites.
- Act as a GCP Quality Management System representative, participating in SOP and work instruction reviews.
- Review and analyze key performance indicator (KPI) data and trends, assessing risks and recommending remedial, corrective, and preventive actions.
- Participate in process improvement initiatives to enhance overall quality management.
- Develop and maintain QA-to-QA relationships with GCP vendors to ensure adherence to quality agreements and participate in vendor joint operating committees as needed.
Qualifications & Skills:
- Bachelor's degree in a scientific or allied health discipline.
- Typically requires 6+ years of experience in clinical trial operations, quality assurance, or regulatory compliance, or an equivalent combination of education and experience.
- Strong knowledge of ICH GCP R2 and global clinical development regulations (e.g., FDA, EMA, MHRA).
- Experience with all phases of clinical trial development involving drugs, biologics, devices, and drug/device combinations.
- Expertise in event management processes, including investigation, root cause analysis, CAPA development, and effectiveness checks.
- Strong ability to assess and address compliance risks while implementing quality management solutions.
- Excellent written and verbal communication skills with both internal and external stakeholders.
- Ability to work independently, effectively prioritize tasks, and meet deadlines.
- Proven ability to manage complex projects and drive initiatives to completion.
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Visio) is a plus.
- Experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics is highly desirable.
- May require up to 10% travel.
This position is ideal for individuals with a strong background in GCP compliance, clinical quality assurance, and regulatory requirements, looking to contribute to the successful execution of high-quality clinical trials.
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