GCP Supplier Quality Consultant

Our firm advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. We are looking for someone to join our team in a vendor management role to manage our audit program.

Responsibilities:
-Manage auditors, handle scheduling with sites and auditors, review audit plants and feedback, and risk management
-Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies
-Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees
-Liaise with suppliers to provide compliance & management support for identified issues arising within outsourced studies
-Lead and/or participate in GCP sponsor and supplier oversight initiatives related to quality
-Provide professional expertise and strong leadership in GCP guidance and regulations, proactively identifying potential areas of non-compliance and risk
-Lead the development and implementation of risk-based GCP supplier audit and compliance strategy and manage supplier audits in compliance with GCP and policies and procedures.
-Assess the impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CQA management.
-Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures·   
-Liaise and collaborate with our clients internal and external business partners to provide guidance and support pertaining to compliance and supplier quality oversight initiatives   
-Analyze, report, and present metrics on supplier quality performance to management; recommend any required actions and monitor implementation.

Requirements:
-Min of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
-Min 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
-Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
-Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
-Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
-Strong technical writing skills; able to write quality positions, audit reports, and procedures.
-Excellent communication skills with the ability to negotiate and influence without authority in a matrix environment
-Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines