Quality Assurance Manager
1 month ago
The Quality Assurance Manager will be responsible for managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. This role will involve planning, maintenance, and implementation of the assigned Global R&D Quality Audit Program with focus on Clinical Development (from early First in Human to late clinical phases) in your region.
Key Responsibilities- Develop the Global CQA Audit Program/s for the assigned Project or and Compliance areas.
- Perform risk assessments, input of information and tracking progress of the assigned Audit Program.
- Implement the Project or Compliance Area Audit Program/s through performance of self-inspections/audits of internal processes/ procedures, 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.
- Approve CAPA plans resulting from audits and inspections.
- Manage individual CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed and closed promptly.
- Directly follow-up on observations resulting from audits of 3rd party vendors and oversee timely CAPA resolution.
- Escalate non-compliances/ trends to Line manager/ Head, Global CQA.
- Analyze audit observations, gaps and systematic issues to help to support continuous improvement within Clinical Development, 3rd party vendors and working functions.
- Evaluation of adequacy and completeness of corrective and preventative action plans (CAPAs) originated from audits, deviations and/or inspections for assigned Compliance Areas.
- Includes identification of non-compliance trends and systematic risks and escalation of non-compliances/ trends to the Director, Global CQA.
- Help conduct pre-inspections, mock-inspections and related follow-up activities, and review of inspection requested information.
- Support Global R&D Quality Management with hosting and/or facilitating regulatory agency inspection.
- Provide GCP and GxP working consultancy and other Clinical regulatory expertise to support us in maintaining required compliance.
- Provide GCP and process related support.
- Perform GCP review of new/ updated GxP relevant procedural documents, as assigned.
- Support the development and continuous improvement of the Global R&D Quality System (tools, E-Systems).
- Be the primary point of QA contact for the local and global staff of the Clinical Organization for the assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP within Global R&D Quality.
- Collaborate with the Global R&D Systems and other Operational Excellence groups to improve processes identified through CAPA, internal compliance monitoring and industry best practices/trends.
- University degree (MSc/Diploma) in Scientific Discipline/ Life Sciences or other related disciplines.
- Minimum of 5 years of professional work experience in clinical research in the Pharmaceutical Industry, minimum 4 years' experience in a Quality Assurance or Compliance function globally operating.
- Work unassisted and as a team player when working in a group.
- Work unassisted and as a team member.
- Conduct audits unassisted and/or as part of a team.
- 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.
- Experience working in a Quality related and/or Process Management related environment /role.
- Strategic development and analytical skills.
- Experience managing processes with a continuous improvement approach.
- Analyze complex circumstances and problems, and to guide appropriate actions.
- Experience in resource and budget management.
- Work and collaborate at all levels within an organization.
- Domestic (and International Travel, as assigned) required.
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