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 the second largest influenza vaccine company 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!

In order to strengthen our Commercial team for the Emerging Europe Cluster, we are currently recruiting for a

Regional Quality Officer & Regional Regulatory Manager Emerging Europe (all gender)

Location: Hattersheim (Germany), Warsaw (Poland), Prague (Czech Republic), Budapest (Hungary)

The position is the primary interface between the business partners/ CSLB rep offices / affiliates, and global Quality Assurance and Global Regulatory Affairs and Logistics in assigned territory of Emerging Europe (EEU) including Baltic countries, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia and Ireland.
The position is responsible for compliance regarding all internal policies / procedures and local regulations in the field of Quality Assurance and Regulatory Affairs within EEU region.
This position will manage and continually develop compliance activities related to Quality Assurance and monitor Key Performance Indicators (KPIs) for the EEU region in accordance with established standards.
In addition to the aforementioned role/responsibility, the incumbent is also assigned as Deputy for the Regional Safety Officer for the Emerging Europe region (RSO EEU)

Main Responsibilities and Accountabilities:

Regional Regulatory Manager for the Emerging Europe region (RRM EEU)

In close liaison with Global Regulatory Affairs (GRA), the incumbent is responsible to support regulatory activities in the EEU region including but not limited to:
  • Ensure that labeling texts and Package Materials are in compliant with approved regulatory status (in close collaboration with Supply Chain and Area Manager EEU)
  • Support of regulatory activities for CSL Behring products in the EEU region
  • Responsible for collection and communication of local regulatory requirements; keeping GRA informed.
  • Ensure appropriate training of business partners / service providers on adherence to all applicable CSL Behring global procedures
  • Due Diligence process in collaboration with GRA in the selection of qualified regulatory personnel at the distributor/service provider
  • Establishment and maintenance of contractual agreements for Regulatory Affairs services activities in collaboration with GRA
  • Review and initiation of the reimbursement of invoices of regulatory service activities received from Business Partner / Service Provider
  • Management of Change Control processes, e.g. product launches, CAPAs, etc. for the EEU region


Regional Quality Officer for the Emerging Europe region (RQO EEU)

In close liaison with Global Quality, the RQO is responsible for Quality Assurance activities in the relevant country/region, including but not limited to:

  • Development, Implementation, and maintenance of local or regional Quality Management System as required
  • Align and map local procedures with global procedures
  • Support CSL Behring in the frame of inspections and audits in the region and keep all relevant stakeholders informed of upcoming audits and/or inspections by any Regulatory Authorities / Notified Body in the Territory (e.g. GMP, GDP); Closely liaises with the relevant functions in the preparation and during the conduct of the inspection / audits; this include role of follow-up coordinator and responsibility for CAPA plans
  • Responsible for having Quality Agreements with business partners / service providers in the EEU region in place
  • Support qualifications of Business Partners
  • Support new established affiliates in quality matters
  • Having awareness of the issues surrounding falsified/counterfeit medicines, recalls or any requests from Regulatory Authorities in the EEU region
  • Management of any risk measurement to be taken in the EEU region, e.g. recalls, management of potential counterfeit products in the EEU region in cooperation with Supply Chain and Global Quality and/or the manufacturing sites. This includes communication and guidance to all distributor markets and ensuring that products are quarantined or withdrawn from the market and destroyed with appropriate documentation in the country or any other measures implemented as directed by the Global Quality function of the affected site
  • Ensure Training of internal and external partners in accordance with GxP requirements and/or CSL Behring policies/procedures
  • Coordinate the handling of Pharmaceutical Technical Complaints (PTCS), temperature excursions, and any deviations from the EEU region
  • Provide a local interface between GCSP and Quality Assurance (QA), ensuring that all PTCs received in the EEU region are monitored by the RSO
  • Tracking of any non-compliance with respect to local requirements
  • Management of Change Control for the EEU region, e.g. product launches, changes to GxP processes, etc.
  • Responsible for the ongoing support for existing quality processes and systems including training; document management; TrackWise applications

Deputy Regional Safety Officer for the Emerging Europe region (RSO EEU)

Position Qualifications and Experience Requirements:

  • University degree in natural or life science (with a broad understanding in medicine) or University degree in human/veterinary medicine or pharmacy
  • At least 3 years' experience in Regulatory Affairs, Quality Assurance areas in an international pharmaceutical company
  • Fluent in English (oral and written) and MS Office
  • Knowledge in current European regulatory and GxP legislation and guidelines
  • Competency of coordination with different departments / functions / partners - national and international, internal and external
  • Project management experience, process-oriented
  • Collaborates with Global Process Owners and Leaders to define and deliver on expected project deliverables and value
  • Represents projects for the Affiliate at required internal and external meetings to assure that priorities are communicated and understood, and that progress/delays/issues are reported


Worker Type:
Employee

Worker Sub Type:
Regular
Mission
We're connecting diverse talent to big career moves. Meeting people who boost your career is hard - yet networking is key to growth and economic empowerment. We’re here to support you - within your current workplace or somewhere new. Upskill, join daily virtual events, apply to roles (it’s free!).
Are you hiring? Join our platform for diversifiying your team
Regional Quality Officer & Regional Regulatory Manager Emerging Europe (all gender)