KEY RESPONSIBILUTIES:
1. Support the development and maintenance of the Global CQA Audit Program/s for the assigned Project or and Compliance areas including:
· Development and execution of the assigned Project or Compliance Area Audit Program/s
· Performance of risk assessments, input of information and tracking progress of the assigned Audit Program
· Coordination with global and regional clinical development and operational functions to ensure a current CQA risk based audit program, including update of specific risk matrices in the assigned compliance areas.
2. Execute 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 in order to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines, legal requirements and relevant GXPs.
· Development, review and issuance of Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations
· Review and 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 in a timely manner
· Directly follow-up on observations resulting from audits of 3rd party vendors and oversee timely CAPA resolution
· Identify non-compliance trends and systematic risks for assigned areas of responsibilities
· Escalate non-compliances/ trends to Line manager/ Head, Global CQA
3. Analyze audit observations, gaps and systematic issues to help to support continuous improvement within Clinical Development, 3rd party vendors and interfacing 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 as well as escalation of non-compliances/ trends to the Director, Global CQA.
Position Description CQA Manager– V 24Oct2023 – Page 3 of 4
4. Support the conduct of pre-inspections, mock-inspections and related follow-up activities, and review of inspection requested information.
5. Support Global R&D Quality Management with hosting and/or facilitating regulatory agency inspections.
Provide GCP and relevant GxP interfacing consultancy and other Clinical regulatory expertise to support the organization in maintaining required compliance:
Provides GCP and process related guidance and support
Perform GCP review of new/ updated GxP relevant procedural documents, as assigned
6. Support the development, maintenance and continuous improvement of the Global R&D Quality System (processes, tools, e-systems).
7. Serve as 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.
8. Collaborate with the Global R&D Systems and other Operational Excellence groups to drive continuous improvement initiatives identified through CAPA, internal compliance monitoring and industry best practices/trends.
9. Other duties as assigned

ESSENTIAL CRITERIA:
1. University degree (MSc/Diploma) in Scientific Discipline/ Life Sciences or other related disciplines.
2. 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, preferably globally operating.
3. In depth knowledge of industry regulations and clinical development processes with emphasis on local and international standards and regulations and associated GxP guidelines.
4. Experience in a management role is desirable.

其他信息

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