Under general direction, ensures that overall Quality Oversight and compliance with Gx. P regulatory requirements is provided throughout the life cycle stages from procurement, implementation, run, to decommissioning of computerized systems for US region. Participate in project teams to provide approval of project Validation documentation according to applicable approval matrix or procedures. Monitor compliance and ensures adherence to regulatory expectations, company procedures for computerized... more details
The Opportunity
- Under general direction, ensures that overall Quality Oversight and compliance with GxP regulatory requirements is provided throughout the life cycle stages from procurement, implementation, run, to decommissioning of computerized systems for US region.
- Participate in project teams to provide approval of project Validation documentation according to applicable approval matrix or procedures.
- Monitor compliance and ensures adherence to regulatory expectations, company procedures for computerized systems.
- Be a Subject Matter Expert (SME); you will provide quality oversight and approval of change controls, deviations, and investigations, CAPAs, and Periodic Review assessments involving GxP Computerized Systems.
- Participate in vendor / supplier audits/assessments and qualification activities involving GxP computerized systems as a Subject Matter Expert.
- Participate in internal GxP audits of computerized systems as an subject matter expert..
- Support GxP health authority inspections by serving as subject matter expert for computerized systems topics.
- Contribute to QMS improvements and help develop quality standards in computerized systems.
- Provide guidance on quality and regulatory requirements to project teams, company partners, and other teams on GxP compliance relating to computerized systems.
- Foster relationships with main I&T and R&D Team members and subject matter experts.
The Role
- Support the implementation and ensure compliant operation of GxP relevant R&D systems as QA.
- Ensure that systems are built following applicable procedures and are fit for their intended use.
- Ensure that system periodic review and access management reviews are completed promptly.
- Support audit trail review completion by the business and ensures audit trail availability for GxP systems.
- Ensure and monitor compliance with CSV standards of the corresponding IT systems and Infrastructure.
- Provide QA guidance for R&D GxP Global computerized systems, including the approval of GxP risk assessment, standards, and documents for all GxP systems, and non-GxP relevant systems related to the establishment of GxP applicability.
- Provide subject matter expertise, as directed by the DQ R&D Systems Lead, to support several training programs (e.g., Data Integrity), process improvement, change management projects (e.g., system separations / integrations), computerized system vendor / supplier audits and IT vendor qualification activities.
- Provide QA oversight and approval of project and operational changes, deviations and investigations involving GxP Computerized Systems, including approval of CAPA plans and subsequent tracking of implementation aligned actions.
- Ensure IT procedures and tools integrate and align with QAIT and GxP computerized system validation (CSV) requirements.
Education
- Bachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science.
Experience
- 5+ years' experience in Quality, IT or Validation.
- Pharma/Biotech or similarly regulated environment experience desirable.
- Experience in Quality Assurance, IT, Quality Control, Validation, Production, or Regulatory Affairs.
- Knowledge of GxP, GAMP, FDA, and EMA requirements specifically CFR21 part11 and Annex 11.
- Work with important partners at all levels of the company.
The expected base salary range for this position at hiring is $95,000- $130,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for you are determined by qualifications, skill level, experience, competencies, and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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.
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