Brookfield

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.
• Life cycle maintenance: Prepare applications, variations, labelling changes and renewals documents for the registered products with the Regulatory Departments of the manufacturing site.
• 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 PV Training Responsible and or Coordinator for the Colombia Affiliate to ensure the required training for the affiliate and third parties are in place and performed annually.

Supplier and Quality Agreements

• Supports maintenance of Quality Agreements between CSL Behring Colombia third party logistics (3PL) and third party laboratory providers and manufacturing sites.
• Collaborates with Global Supplier Quality and Global Logistics to ensure that an adequate auditing program which covers self-inspection and external auditing of supply chain partners including 3PL is implemented and effective

Change Control

• Supports or coordinates changes to GxP processes, SOPs and other critical documentation. Assess impact of change to current business practices and communicates requirements to impacted parties in a timely manner.

Product Technical Complaints

• Supports the investigation and reporting of Product Technical Complaints (PTC) originating in Colombia according to CSL global procedures.
• Serves as local interface between GCSP and Quality, ensuring that all PTCs originating in Colombia are monitored so that any PTC that also meets the criteria for an Individual Case Safety Report (ICSR) is appropriately handled in accordance with GCSP procedural documentation

Product Release

• Final administrative release of all affiliate product batches in Colombia on Dispatcher and SAP and associated processes. Liaison with manufacturing site Qualified Persons and batch release personnel as necessary. Manages deviations impacting the release of finished products and work quickly to resolve the issues. Serves as the main point of contact for damages/deviations that occur at the 3PL or third party laboratory.

Recall and Field Action

• Supports any field action or recall activity as required by the Recall Team. Collaborates with Customer Service and Medical Information to promptly resolve customer inquiries relevant to product quality and possible temperature/storage concerns following release of product from supply chain partners or healthcare providers to the customer. Is responsible for confirming product quality or storage questions with the sites of manufacture.
• Supports investigation of reports of counterfeit product discovered in the Colombia, regardless of the product location of manufacture. Provides batch number verification through electronic systems for all required customer complaints or inquiries
• Responsible for Industrial Safety that includes industrial waste management and employee safety. Keep updated SOPs regarding Safety at the QA site and commercial offices.
• Coordinates and executes the orders of new product to supply chain contact abroad . Collects the necessary information from management and thoroughly informs on potential stock outs or write-offs.
• Manages Media Press enquiries re technical features of products or procedures related to them. Keeps him or herself trained in media press response in order to protect company image
• Keeps records of product registration available for consultation at all times and manages to provide 24/7 ability to respond local Health Authorities enquiries and ensures that a deputy is appointed and properly trained.
• Periodically reviews and corrects the needed safety aids for the building facilities making sure that they are safe to all employees and they know personal risks in order to minimize safety events to zero.
• The LSO provides local interface between GCSP, Quality and Medical Affairs / Commercial Operations, ensuring that all medical information enquiries received locally are screened, and that any enquiry that also meets the criteria for an ICSR, is appropriately handled in accordance with GCSP procedural documentation.
• Also responsible for liaising between GCSP, Quality and Medical Affairs / Commercial Operations in regards to named patient programs, post-authorization studies or any other activity/initiative run by Medical Affairs or Commercial Operations that may involve handling/receipt of any safety information. Acts as the Pharmacovigilance Agreements Owner within the territory based on other applicable Supply/Distribution and Quality Agreements

Your Skills and Experience:

• Pharmacist university degree (essential). Postgraduate or MBA (desirable).
• From 5 to 10 years’ experience in the pharmaceutical industry (Biotech segment) , at least 5 years of regulatory experience (essential).
• Experience with Good Distribution Practices (GDP) systems implementation and utilization and Good Pharmacovigilance Practices (GVP) is desirable. 
• Must be comfortable and have experience working in a global, matrix organization.
• Language: Fluent in Spanish and English

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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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