Details for the position are as follows:
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- 12-month contract to start with the possibility of extension or conversion depending on performance and business needs
- Rate: $166-172.41 an hour
- Location: Cambridge, MA -Hybrid open to candidates able to relocate at their own expense.
- Provides quality assurance oversight of the global clinical research programs in Oncology Business Unit (OBU) with the overall goal of inspection readiness.
- Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
- With the guidance of Head of Clinical Program Quality, TAU, defines and implements a risk-based program audit strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate and timely investigations and mitigations are in place.
- Leads the clinical pre-approval inspection (PAI) readiness programs, the management of the inspection and the response and follow-up activities. Ensures that any inspection risks are well-communicated and mitigated. These inspections include both sponsor and investigator sites.
- Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
- Assume complex assignments on issues or studies where there is no precedent
- Mentor and provide support to Manager level CPQ personnel, as needed
- Represent CPQ in program-specific meetings and global CPQ team assigned
- Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical study delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and involve technically complex assignments. Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CPMQ management. Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
- Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Lead GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions
- Analyse, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation.
- BA/BS degree required; advanced degree preferred.
- Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Must have at least 7 years of experience with GCP-focused Quality Assurance, where GCP quality responsibilities represented the primary focus of the role.
- Must have Oncology Experience.
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