Hi, My name isYogesh Gathe and, I am a senior recruiter working with Experis a part of ManpowerGroup. I have an excellent opportunity with a direct client of ours. This opportunity is urgent and looking to move very quickly, please apply by sending your email or forwarding on to anyone you know who might be a fit. I am looking forward to connecting with you! Job Title: Sr. Consultant of R&D Quality OperationsLocation: REMOTE (Boston, MA) Job Type: 6+ Months Contract Position Summary This leader will:Quality Key Point of Contact for major processes/platforms such as TMF, CRO oversight, medical device. Drive the excellence of major processes/platforms in Research & Clinical Development Quality Operations team working with R&D owners of these processes. Provide Quality Operations guidance to other Quality Operations Leads and Clinical Development teams utilizing these processes/platforms. Be accountable for the development and implementation of a global strategy to plan, control, and improve quality for assigned programs including several pivotal/registry studies in the Clinical Development portfolio, partnering with peers to assure quality coverage of respective studies, influencing Clinical Development stakeholders to successfully embed a strong Quality culture. Identify, evaluate, and drive the remediation of fundamental risks and quality issues within Clinical Development program(s) to drive quality, in collaboration with Clinical Development, in CLIENT's portfolio. Drive inspection readiness fP inspections in assigned portfolio, partnering with the Director, Inspection Management, to assure successful outcomes during submission-related and unannounced inspections. Provide mentoring to Quality Operations Leads, assuring program alignment and team engagement. Principal Responsibilities
- In alignment with Sr. Director Research and Clinical Development Quality Operations, develops an overarching strategy related to proactive and sustainable quality and compliance for the assigned programs/portfolio.
- Quality Key Point of Contact for major processes/platforms such as TMF, CRO oversight, medical device. Drive the excellence of major processes/platforms in Clinical Development Quality Operations team working with R&D owners of these processes. Provide Quality Operations guidance to other Quality Operations Leads and Clinical Development teams utilizing these processess/platforms.
- Serve as the lead for compliance with GXP (e.g., GLP, Google Cloud Platform and GVP) requirements for multiple programs including several pivotal / registry studies.
- Serves in an advisory/ consultative role in compliance related manners and supports Program teams in deviation management and implementing corrective and preventive actions. Promotes a culture of inspection readiness and sustainable compliance.
- Works with other RDQ functions to perform program specific root cause analysis of compliance issues and where applicable provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management.
- Identify, evaluate, and drive the remediation of fundamental risks and issues (RBQM) within Research and/or Clinical Development to drive quality, in collaboration with Research and Clinical Development, in CLIENT's portfolio.
- Leads and supports risk-based quality management (RBQM) for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan - Do - Check - Act.
- Participates in Due Diligence and integration activities as appropriate.
- Ensures appropriate corrective and preventive actions (CAPAs) are completed in a timely manner. As appropriate escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management and appropriate internal R&D functions.
- Serves in an advisory/ consultative role in development of audit strategy for clinical programs, process and vendor audits. Collaboratively works with Head, R&D Audit Operations to ensure a robust clinical audit strategy.
- In collaboration and coordination with other R&D functions (e.g. DOQS), develops appropriate level of quality governance for defined clinical vendors and establishes and monitors robust vendor quality performance metrics. Consults with other R&D functions in developing appropriate vendor quality oversight plans and processes.
- Leads development and/or review of Study related documents, SOPs, Policies, etc., as needed.
- Active participation in meetings driving quality and business performance.
- Develop, lead and Support Organizational/Enterprise level initiatives.
- 10 or more years' experience in Google Cloud Platform and quality assurance in both tactical and strategic capacities
- Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
- Significant experience with GxP investigations, risk assessments and CAPA management
- Experience participating in regulatory inspections
- Functional planning experience and ability to develop functional vision, priorities and tactics
- Experience with multinational products and regulations as well as with mandated risk management plans
- Bachelor's degree in life science required. Advanced degree strongly preferred.
- Decision Quality
- Being Resilient
- Attracts and Develops top talent
- Drives Results
- Strategic Mindset