Specialist I, (R&D QA Systems)

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Purpose:

The incumbent will be a member of the global R&D QA System Team assisting the R&D QA organization with managing archival systems, supporting external audits, change controls, DR/CAPAs, vendor qualification, ODCAs and document management work flows.  Provides support for global R&D QA organization in all cGXP compliance related matters, including assurance that all aspects comply with cGXPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements.

• This role will work remotely 100%
• 8 hour work days are the standard, but work times will vary based on support of team members in different time zones.

• Establishes and maintains complex departmental filing and archival systems (both paper and electronic documentation) according to applicable processes and system requirements
• Assists with management of external audit resources
• Maintenance of systems and databases used or owned by CQA, as well as the assignment and tracking of departmental trainings, to include serving as department administrator for applicable Learning Management Systems (LMS)
• Assists with the scheduling, preparation and reporting of internal and external audits
• Supports management of deviations and CAPAs (internal and external)
• Supports development and deployment of Quality procedures and internal training programs and initiatives
• Compiles, formats and archives confidential and non-routine correspondence and documents
• Maintains department directories, calendars and organization charts
• Is proactive with issues that arise and impact on business activity and ensure that senior management is notified
• Manages and tracks departmental vendor contracts and invoices and may act as primary contact for departmental budget reporting
• Supports regulatory authority inspection readiness projects as directed, preparation for inspections, on-site logistical support during GXP inspections and coordination of inspection responses
• Assists with compiling, formatting, analyzing, and reporting quality metrics.
• Organizes and prepares technical departmental presentations and graphs in Microsoft PowerPoint
• Provides support to other tasks and initiatives within R&D QA as directed.
• Organizes domestic and international meetings, teleconference with multi-zone for global CQA Head, CQA Regional Leads or manage their calendar(s)
• Organizes domestic and international travel arrangements.

• Bachelor’s degree in Science/ Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
• Advanced computer literacy required: Word, Excel, PowerPoint, Project, and Visio.
• Minimum of 1 year experience in FDA regulated Quality Systems; including document control, CAPA, and training preferred.
• Knowledge of clinical research regulations, including ICH E6 Good Clinical Practice, and 21 CFR Parts 50, 54, 56, 312, and 314 preferred.
• CRO or clinical trial background desired
• Data analysis or analytics and/or project management experience preferred.
• Experience with quality management software; Trackwise experience preferred.
• Ability to work hours supportive of different time zones