Regulatory, Quality

**The Opportunity**:
Reporting to the General Manager of our Colombia affiliate, as the Regulatory, Quality & PV Manager, you will be responsible for Regulatory Affairs, Quality Assurance, and Pharmacovigilance, including the supervision of third party providers in those areas and report to functional departments the relevant information.

**_ As Regulatory Affairs Responsible 70%:_**
- The Regulatory Affairs Responsible is in charge to register and maintain the marketing authorization up-to-date to ensure the supply of CSL products in compliance according to the applicable regulation in Colombia and CSL policies and SOPs.

**_ As Quality Responsible (LQO) 15%: (Technical Director):_**
- The LQO is the responsible party in the establishment and maintenance of local, affiliates and global quality procedures. It is also responsible for training all internal and external personnel (where necessary) performing GxP activities on behalf of CSL Behring.
- In addition, you will be responsible for the assessment and timely completion of product deviations, Product Technical Complaints, CAPAs, Change Control, Product Recalls and Product Counterfeit investigations. Coordinates the submission of finished product samples to the testing laboratory and review and approves the test results.
- The LQO supports regulatory inspections of the affiliate and collaborates with Customer Service, Medical Information and Global Logistics to resolve customer inquiries relevant to product quality and possible temperature/storage concerns according to local legislation.
- You will be responsible to supervise the third party service provider that test the products in order to release them into the market. Is the legal responsible for the quality of the products in front of local authorities giving them her/his own signature guarantee.

**_ As Pharmacovigilance responsible ( LSO) 15%:_**
- The LSO is the legal responsible person for Competent Regulatory Authority in the establishment and maintenance of the local PV system, which includes Pharmacovigilance for all CSLB products licensed, marketed or supplied within the territory, compliance with international regulations (e.g.GVP), inspection readiness/support, pharmacovigilance procedural documentation development and maintenance of local information relevant for the Pharmacovigilance System Master File.
- The LSO ensures ICSR Handling, submission of expedited ADR reports, aggregate safety reports and safety signals as required to local competent regulatory authorities in accordance with the applicable regulatory requirements ensuring business continuity plan exists, unless expedited reporting is directly performed by a CSL PV site.

**The Role**:
**_ Regulatory Affairs_**
- Collect, translate and present the necessary information to local authorities in order to obtain registration of products.
- Responsible for the collection, validation and internal communication of local requirements
- Regular reporting to senior management and peers to ensure alignment of strategic planning.
- Coordinate labelling implementation between sites, markets and Supply Chain to ensure that the products can be imported
- Coordination of activities required to ensure that only compliant products (i.e., matching the approved regulatory status) are supplied (close collaboration with Intercontinental Supply Chain), especially for labeling changes.
- Responsible for the communication with the local Authorities

**_ Quality Responsible (LQO)_**
- Manages Quality Assurance SOPs compliance in order to release the products after
- Importation and before going to the market. Is responsible to trace products and organize and implement product recall whenever needed. Assess and train specific personnel in new products. Is the legal responsible for the quality of the products in front of local authorities giving them his own signature guarantee. Drive continuous improvement and efficiency initiatives in Quality Operations

**_ Quality Compliance_**
- Serves as the Local Quality Officer for the CSL Behring Colombia Affiliate. Ensures compliance with all CSL Behring requirements for the affiliate operations in Colombia and CSL Behring global SOPs, policies and local regulatory requirements.
- Creates and maintains (when required) local quality SOPs according to the CSL Behring global quality policies and local regulatory requirements. Ensures that the local procedures are compliant with the Country specific regulations and that the Affiliate is compliant in its implementation. Contribute to Global Quality procedures when requested.
- Ensures accurate, reliable recording, storage, archiving system for all GxP related documents.
- Maintains the affiliate ready for local regulatory inspections

**_ GxP and Pharmacovigilance (PV)Training_**
- Establishes and maintains a GxP training program in the Colombia Affiliate for functions requiring GxP training documentation including personal training records.
- Serves as the GxP and