Global Quality, QA Clinical Manager
100% US Remote
6 month contract with potential conversion
*This role would require up to 30% travel*
We are partnering with a global pharmaceutical company that specializes within addiction medication.
Currently, we are supporting a Global Quality, QA Clinical Manager that will lead QA processes, work cross-functionally with the Quality, Functional Compliance team and R&D to ensure clinical trials meet global regulatory and business requirements.
The successful professional will have extensive experience, within GCP auditing (currently there are 3 sites) including, but not limited to site investigation, IA audits and vendor management. Auditors with clinical experience!
The Opportunity:
Lead, implement and maintain clients GCP QA audit program to plan to support aspects of Phase I-IV global clinical trials managed by Global Medicines Development (GMD).
Lead qualification, routine and for-cause audits of Clinical Research Organizations (CRO), investigator sites, laboratory and data management vendors as well as other clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
Conduct internal audits to assess effectiveness of clients GCP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits.
Maintain the approved supplier list (ASL) for Clinical suppliers.
Ensure timely issuance of audit reports, audit observations, oversee audit response process and drive audits to closure.
Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
Evaluate audit observation trends and compliance risks and escalate to QA Management, as required.
Reporting of key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
Support the cross functional site Quality Management Review (QMR) meetings.
Maintain and enhance existing procedures including electronic system configuration and reports that are utilized to manage the clinical audit program.
Ensure timely collaboration with Global Medicines Development staff (Compliance and Operations) to ensure any non-compliance is elevated appropriately and addressed in a timely manner.
Advise Global Medicines Development team regarding aspects of GCP and compliance to standard operating procedures and regulatory requirements.
Prepare Quality Agreements for review and approval, as applicable.
Lead specific global R&D initiatives aimed to strengthen the Quality Management System, as required.
Maintaining current working knowledge of regulations that impact on role.
Required Experience, Skills, and Education:
Bachelor of Science or Bachelor of Arts degree in a life science. Post graduate degree is preferred.
Proven track record of GCP QA auditing experience in a regulated industry such as FDA, pharmaceutical or biotech.
Ability to travel with adequate notification approximately 30% of working hours is required.
Thorough understanding of regulatory requirements for the conduct of clinical trials for drug product, devices or combination products. GCP audit experience in the North America and EU required.
Clear understanding of international guidelines (ICH, cGCP) including study conduct, statistics and data management.
Practical demonstrated application of drug/combination product regulatory requirements (e.g. Clinical Trial Regulations (ICH E6(R2), E2A, E8(R1) and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC; 21 CFR 58).
Prior experience working with CROs and/or outsourced organizations is a definite plus.
Experience in Competent Authority inspections.
Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (eg. Root Cause Analysis, etc.)
Experience in auditing REMS programs and/or Pharmacovigilance activities is a plus.