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Global Clinical Quality Assurance Manager
vor 2 Wochen
As a CQA Manager, you will be managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. Under supervision of the Regional Head CQA, you will be responsible for planning, maintenance and implementation of the assigned Global R&D Quality Audit Program with focus on Pre-Clinical, Early Clinical and Clinical Development in your region.
You will oversee the execution and performance of the Global CQA Quality System elements in the assigned compliance area including Management of CAPAs and Deviations, Inspection Preparation and Management, Change Management, Continuous Improvement, Compliance, Governance and Reporting, 3rd Party management, Regulatory Intelligence, Pre-Clinical/Clinical IT-Systems and Procedural Quality Assurance.
You will liaise and interface with global and regional customers in order to assess and support compliance with international guidelines (e.g., ICH-GCP, GCLP, GLP and GVP), applicable international and local regulations, and global quality standards in the pre-clinical and/or clinical development field.
**Your responsibilities, in detail, will include**:
- Support the development and maintenance of the Global CQA Audit Program/s for the assigned Therapeutic and Compliance areas, including performance of risk assessments, input of information and tracking progress of the assigned Audit Program
- Performance of audits of internal processes/ procedures, clinical investigator sites, clinical databases, study reports, contract CROs/laboratories/vendors, and/or Independent Ethics Committees/ Institutional Review Boards, issuance of Audit Reports
- Review, approve and manage CAPA plans resulting from audits and inspections (including a risk assessment, root cause analysis and effectiveness measures)
- Identify and escalate non-compliance trends and systematic risks for assigned areas of responsibilities to Line manager/ Head, Global CQA
- Support the conduct of 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 inspections
- Provide GCP/GCLP/GLP/GRLP consultancy and other Pre-Clinical/ Clinical regulatory expertise to support the organization in maintaining required compliance: Provides GCP/GCLP/GLP/GRLP and process related guidance and support. Perform GCP/GLP review of new/ updated GxP relevant procedural documents
- Support the development, maintenance, and continuous improvement of the Global R&D Quality System (processes, tools, E-Systems).
- Serve as the primary point of QA contact for the local and global staff of the Pre-Clinical and Clinical Organization for the assigned compliance areas ensuring the timely communication of quality risk and compliance as related to GCP/GCLP/GLP and GRLP within Global R&D Quality.
- 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.
**Position Qualifications and Experience Requirements**:
- Minimum: University degree (BSc/MSc/Diploma) in Scientific Discipline/ Life Sciences or another related discipline
- Minimum 5 years of experience in pre-clinical/ clinical research in the Pharmaceutical Industry
- Minimum 4 years of experience in a Quality Assurance or Compliance function, preferably globally operating
- In-depth knowledge of industry regulations and clinical development processes with emphasis on local and international standards and regulations and associated GCP/GLP/GCLP guidelines.
- Must be able to conduct audits independently and/or as part of a team
- Domestic and International travel is required.
- Experience in a project management role is desirable.
- Demonstrated ability to navigate and negotiate competing priorities in a challenging environment
- Proven experience in resource and budget management
- Ability to work and collaborate at all levels within an organization.
- Excellent communication and training skills, including English language skills
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
