Current jobs related to CQA Management/Auditor - Americas USPA King of Prussia CSL Behring - CSL Behring

  • CQA Management/Auditor

    4 days ago

    King Of Prussia, United States CSL Behring Full time

    The OpportunityThe 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...

  • CQA Management/Auditor

    1 day ago

    King of Prussia, United States CSL Behring 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...

  • CQA Management/Auditor

    5 months ago

    King of Prussia, United States BioSpace, Inc. Full time

    Job Details 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...

  • CQA Management/Auditor

    5 months ago

    King of Prussia, United States CSL Behring Full time

    The OpportunityThe 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...

  • CQA Management/Auditor

    1 month ago

    King of Prussia, Pennsylvania, 19406, Montgomery County, PA, United States CSL Behring Full time

    The OpportunityThe 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...

  • Staff Auditor

    1 day ago

    King of Prussia, United States Universal Health Services Full time

    Responsibilities One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. During the year, UHS was again recognized as one of the World's Most Admired Companies by Fortune; and listed in Forbes ranking of America's...

  • Senior QA GCP Manager

    2 days ago

    King of Prussia, United States Exelixis Full time

    SUMMARY/JOB PURPOSE:Responsible for assisting in the development, implementation and maintenance of QA systems and activities supporting GCP and PV operations. Provides assistance with planning and conducting audits of vendors and associated documentation activities.Essential Duties And Responsibilities:Responsible for assisting in the development of...

  • Front Desk Agent

    2 weeks ago

    King of Prussia, United States Concord Hospitality Full time

    Description The Alloy a DoubleTree by Hilton located in King of Prussia is seeking a Front Desk Agent/Night Auditor to join our Front Office Team! We are looking for people that have a passion to serve others! Working at the front desk means you are at the hub of the hotel with the most interaction with our guests. Your role is key to the overall experience...

  • Senior Auditor

    1 day ago

    King of Prussia, United States UGI Full time

    Requisition Number: 25131 UGI Corporation (NYSE: UGI) is a holding company that distributes and markets energy products and services through our subsidiaries and the company's common stock is a balanced growth and income investment. UGI Corporation has paid common dividends for more than 135 consecutive years. In addition to a challenging career and...

  • Quant Audit Manager

    2 days ago

    King of Prussia, United States Truist Inc Full time

    The position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to create a profile, which will let you see your application status and any communications. If you already have a profile with us, you can log in to check status. Need...

  • Accounting Manager

    9 hours ago

    King of Prussia, United States Soni Resources Full time

    A national building supply company is seeking an Accounting Manager to join their Accounting and Finance team. The Accounting Manager works directly with the Controller and will manage a team of 10 direct reports. The Accounting Manager oversees, mentors, and develops accounting department staff while providing financial leadership across the organization....

  • Environmental Project Manager

    3 days ago

    King of Prussia, United States GHD Full time

    There’s no pledge more important than the one we make to look after our environment, and we’re committed to helping you do exactly that.Join us as we strive to ensure a sustainable future for our communities and the world we live in.Become part of our global network of skilled engineers, scientists, auditors, planners and environmental specialists, all...

  • Relationship Manager

    3 days ago

    King of Prussia, United States GHD Full time

    There’s no pledge more important than the one we make to look after our environment, and we’re committed to helping you do exactly that. Join us as we strive to ensure a sustainable future for our communities and the world we live in. Become part of our global network of skilled engineers, scientists, auditors, planners and environmental specialists, all...

  • Senior Tax Manager

    1 week ago

    King of Prussia, United States Qlik Full time

    What makes us Qlik?A Gartner Magic Quadrant Leader for 14 years in a row, Qlik transforms complex data landscapes into actionable insights, driving strategic business outcomes. Serving over 40,000 global customers, our portfolio leverages pervasive data quality and advanced AI/ML capabilities that lead to better decisions, faster.We excel in integration and...

  • Senior Tax Manager

    3 days ago

    King of Prussia, United States Qlik Full time

    What makes us Qlik?A Gartner Magic Quadrant Leader for 14 years in a row, Qlik transforms complex data landscapes into actionable insights, driving strategic business outcomes. Serving over 40,000 global customers, our portfolio leverages pervasive data quality and advanced AI/ML capabilities that lead to better decisions, faster.We excel in integration and...

  • Clerical Finance Professional

    2 weeks ago

    King of Prussia, Pennsylvania, United States PSI CRO Full time

    Career OpportunityWe are seeking a detail-oriented and organized Junior Accountant to join our team at PSI CRO. This role offers the opportunity to develop your skills and knowledge in financial operations and contribute to the success of our company.Salary Range: The estimated salary for this position is $58,000 - $68,000 per year, depending on experience...

  • Tax Strategist

    1 month ago

    King of Prussia, Pennsylvania, United States CSL Behring Full time

    Job SummaryWe are seeking a highly skilled Tax Strategist to manage income tax matters and implementation of Tax strategy for the North American region.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.Key ResponsibilitiesManage US federal, state and local tax...

  • Night Auditor- $20/hr

    4 days ago

    Isle of Palms, United States Wild Dunes Resort Full time

    Join us for this incredible opportunity to be part of our Front Office team as a Night Auditor at Wild Dunes Resort in Isle of Palms, just outside of Charleston, SC. Not only will you be part of a remarkable property, but you'll be a part of a company that was recognized as one of Fortunes 100 Best Companies to Work For in 2021! We Offer Excellent...

  • Senior Accountant

    4 weeks ago

    King of Prussia, United States Robert Half Full time

    Job DescriptionJob DescriptionGrowing Non-Profit located in the King of Prussia Area is looking to hire a full-time Senior Accountant with strong knowledge of state, federal and sales tax laws, experience closing the monthly/annual books, building budgets, forecasting, working with auditors, and completing AR/AP activities. As the Senior Accountant, you will...

  • Senior Auditor

    3 days ago

    City of Daşşak, United States FinanceInfos Full time

    Job Highlights Title: Senior Auditor (Finance) Type: Full Time Experience: 2 Years Function: Auditing Location: New York, NY, United States Company: Capital One Company Profile Capital One is founded on the belief that no one should be locked out of the financial system. The bank’s deep commitment to financial inclusion is reflected in its business,...

CQA Management/Auditor

3 months ago

Americas USPA King of Prussia CSL Behring, United States CSL Behring 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:

  • Develop the assigned Project or Compliance Area Audit Program/s.
  • Perform 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:

  • Provide 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. 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.

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.
  • 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.

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