CQA Management/Audit Specialist
3 weeks ago
The Opportunity
Clinical Quality Assurance (CQA) professionals play a vital role in ensuring the integrity and quality of clinical trials. As a CQA Management/Audit Specialist at BioSpace, Inc., you will be responsible for managing global CQA activities in various regions, including Asia-Pacific, Americas, EMEA, and Japan. Your primary focus will be on planning, maintenance, and implementation of the assigned Global R&D Quality Audit Program with a focus on Clinical Development. This includes managing CAPAs and deviations, inspection preparation and management, change management, continuous improvement, compliance, governance, and reporting, as well as 3rd party management and regulatory intelligence.
The Role
1. Develop and implement the Global CQA Audit Program for assigned projects or compliance areas, including risk assessments, tracking progress, and coordination with clinical development and operational responsibilities.
2. Perform self-inspections/audits of internal processes, clinical investigator sites, clinical databases, study reports, contract CROs/vendors, and/or Independent Ethics Committees/Institutional Review Boards to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines, legal requirements, and GxPs.
3. Develop, review, and issue Audit Reports outlining findings categorized according to level of risk and CAPA recommendations, and approve CAPA plans resulting from audits and inspections.
4. Manage individual CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated and identified actions are addressed and closed promptly.
5. Analyze audit observations, gaps, and systematic issues to support continuous improvement within Clinical Development, 3rd party vendors, and working functions.
6. Collaborate with Global R&D Quality Management to host and/or facilitate regulatory agency inspections, and provide GCP and GxP working consultancy and other Clinical regulatory expertise to support compliance.
7. Support the development and continuous improvement of the Global R&D Quality System (tools, E-Systems), and be the primary point of QA contact for local and global staff of the Clinical Organization for assigned compliance areas.
8. Collaborate with Global R&D Systems and other Operational Excellence groups to improve processes identified through CAPA, internal compliance monitoring, and industry best practices/trends.
Your Skills and Experience
• University degree in Scientific Discipline/Life Sciences or other related disciplines.
• Minimum of 5 years of professional work experience in clinical research in the Pharmaceutical Industry, with a minimum of 4 years' experience in a Quality Assurance or Compliance function globally operating.
• In-depth knowledge of industry regulations and clinical development processes with emphasis on local and international standards and regulations and associated GxP guidelines.
• Experience in a management role is desirable, as well as experience working in a Quality related and/or Process Management related environment/role.
• Strategic development and analytical skills, with the ability to analyze complex circumstances and problems, and guide appropriate actions.
• Experience managing processes with a continuous improvement approach, and resource and budget management.
• Ability to work and collaborate at all levels within an organization, with domestic and international travel required.
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