Commercial Quality Supervisor LAN - 2406163240W

　　Description

　　At Johnson & Johnson , the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.

　　Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

　　When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

　　At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

　　We are Janssen.

　　Our mission drives us.

　　Our patients inspire us.

　　We collaborate with the world for the health of everyone in it.

　　Please visit https://www.janssen.com/ for more information.

　　We are searching the best talent for Commercial Quality Supervisor LAN to be in Bogota, Colombia.

　　Purpose: Coordinate, implement and maintain the standard and local regulations related to warehouse and transportation processes. Lead the release process to ensure the correct disposal of the product trough the correct execution of the process defined and the alignment with all the areas related to the process. Provide timely and effective support to the Deliver team regarding operations, to ensure Quality controls in the storage, conditioning, and distribution process, as well as the logistics service levels of the company. Connect with the areas related to the core of processes at the warehouse and transportation to define strategies to guarantee the accomplishment of the standard and regulation required

　　You will be responsible for :

　　Responsible for assuring the product inspection and disposition during the inbound process

　　Responsible for products release, ensuring their correct disposition

　　Guarantee the physical inspection of the products according to what is established by the local regulations of each country, during importation, after R&R process and during reception of product return. In the case of controlled substances, their respective handling must be considered.

　　Review and approve quality issues documented for deviations related to the process under commercial quality deliver responsibility

　　Guarantee product physical ubication of the product at the correct status

　　Review products release metric management ensuring that they are done properly and within the established times.

　　Stop Shipments, Recalls, Field Actions, disposition follow up; to ensure that they are done within the time and following the established procedures.

　　Actively participate in the initiatives of the Commercial Quality team to ensure continuous improvement of logistics operators.

　　Provide support to the implementation and maturity of the Pharma quality management system, including handling-storage & distribution program, supporting the closure of CAPA's, Non-Conformities, Change Controls, and ensuring the correct implementation of the other fundamentals

　　Guarantee compliance with the Repack & relabel standard in the country, evaluating the final disposal of the relevant products and / or conditioning materials in accordance with what is locally approved.

　　Support labeling process guaranteeing the process of materials and product verification

　　Lead product retention management process at the warehouse

　　Support other areas in the investigation process of their deviations, deliver and customer service

　　Lead 3pl surveillance

　　Lead BID´s with information requested for Quality

　　Lead the reception of Health Authority Inspections in LOC and at the warehouse.

　　Lead the reception of customer audits

　　Lead visits from customers

　　Follow up to Gemba Walk results according to the schedule defined in each country, including the follow up and action plan status

　　Manage operation 3PL license requirements

　　SME of the temperature control program

　　Lead strategies for processes related to the Storage and Distribution of products with Temperature Control.

　　Lead implementation of local projects

　　Support Temperature Control Standard (Cold chain qualification, Room’s qualification, Facility mapping)

　　Lead divestiture & acquisitions

　　Guarantee the implementation and correct maintenance of the controlled substances process

　　Participate in the readiness and execution of the internal audits (BRQC, JJRC) being responsible also for the proposal of the activity plan, the implementation and follow up

　　Identify and notify the possible escalation deviations

　　Supervise 3PL activities to assure the compliance of local regulation and Janssen standards

　　Review and approved monthly 3pl metrics, follow up of the action plans related to those

　　Responsible for the CEMS licenses administration

　　Lead the NPI & launches excellence & delisting process

　　Lead the GXP Audit & Inspection management process

　　Support Product development process

　　Guarantee local tests for product in Peru

　　Support the execution of training for 3PL in Peru

　　Support the readiness for local certifications in Peru

　　Support the self-inspection process in Perú

　　Develop and get the approval of Quality agreements with the suppliers for the operational process

　　Focal point with manufacturers

　　Focal point with health authorities when applicable

　　Qualifications

　　Qualifications and requirements:

　　Bachelor degree QFB

　　Minimun 8 years of experience

　　Experience in pharmaceutical industry

　　Bilingual english

　　Organization, planning, and coordination of projects

　　Attention to detail and adherence to procedures

　　Primary Location Latin America-Colombia-Distrito Capital de Bogotá-Bogotá

　　Organization Janssen Cilag S.A. (7060)

　　Job Function Customer/Commercial Quality

　　Req ID: 2406163240W