CSL Behring Clinical Quality Assurance Manager in King of Prussia, Pennsylvania
Clinical Quality Assurance ManagerUnited States of AmericaR-0930942012 CSL Behring L.L.C.
Support the development and maintenanceof the Global CQA Audit Program/s for the assigned Therapeutic and Compliance areas including:
Development and executionof the assigned Project or Compliance Area Audit Program/s
Performanceof risk assessments, input of information and tracking progress of the assigned Audit Program
Coordination with global and regional pre-clinical/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.
Execute the Project or Compliance Area Audit Program/s through:
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 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
Analyze audit observations, gaps and systematic issues to help to support continuous improvement within Pre-Clinical/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.
-Supportthe 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, as assigned
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.
Other duties as assigned
State/Province : Pennsylvania
City : King of Prussia
Street Address : 1020 First Avenue
Primary Location : CSL Behring King of Prussia
Full Time/Part Time : Full Time
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.
CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement