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CQA Management/Auditor

1 month ago

King of Prussia, United States CSL Full time
The Opportunity

The CQA Manager is a global role managing Global CQA activities in the respective regions (Asia-Pacific, Americas, EMEA, Japan) and globally. Under guidance of the Head CQA Operations in the respective region, you will be responsible for 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.

Under guidance of the Head CQA Operations in the respective geographical region, you are responsible for 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, Clinical IT Systems and Procedural Quality Assurance.

You will partner with customers to assess and support compliance with international guidelines (e.g. ICH-GCP), applicable international and local regulations, and global quality standards in all phases of the clinical development field.

The Role

1. Help develop the Global CQA Audit Program/s for the assigned Project or and Compliance areas including:

· Development 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 clinical development and operational responsibilities to provide a current CQA risk-based audit program, including update of specific risk matrices in the assigned compliance areas.

2. 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.

· Development, review and issuance of Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations.

· 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 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 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.

4. 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.

5. Provide GCP and GxP working consultancy and other Clinical regulatory expertise to support us in maintaining required compliance:

· Provides GCP and process related support.

· Perform GCP review of new/ updated GxP relevant procedural documents, as assigned.

6. Support the development and continuous improvement of the Global R&D Quality System (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 improve processes identified through CAPA, internal compliance monitoring and industry best practices/trends.

9. Other responsibilities as assigned.

Your Skills and Experience

· Preferred: 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.

· 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 of 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.

·Quickly 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.

· Work independently and as a team member.

· Use Planning skills.·

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring