Summary
Supervises individual contributors and/or Supervisors, and is accountable for conducting effective performance management. Supports the creation and execution of processes and activities related to fulfilling the quality and regulatory requirements and customer needs for the organization's products and services. Provides and implements strategic direction and vision of continuous improvement and feedback. Ensures close partnership with all marketing company's cross-functional teams and external business partners to identify risks and improvement opportunities and enhance the customer experience.
Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
People LeaderAll Job Posting Locations:
Bogotá, Distrito Capital de Bogotá, ColombiaJob Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for Senior Supervisor Customer/Commercial Quality LAN to be in Bogota.
Purpose:
Coordinate and provide support in the quality system implementation for all activities related to Good Practices (pre and post marketing) in the LOC, ensuring that the QMS complies with the J&J Quality Policy requirements.
Apply regulations and standards and ensure the quality system is properly maintained.
You will be responsible for:
- Coordinate and provide support to the development and implementation of Quality Management System applicable to the LOC activities.
- Ensure that the documents related to the GxP processes are prepared, reviewed, approved, implemented, and updated appropriately.
- Coordinate and execute the program of periodic internal and external audits.
- Participate in the Corporate audits (internal, BRQC, JJRC) being also responsible for the preparation and supervision of the action plans with the departments involved and the follow-up of these plans until the closing of the observations.
- Monitor the inspections of the health authority to the LOC and other relevant activities such as field alerts, recall actions, regulatory Actions and inspection reporting in the applicable system.
- Manage events, deviations and verify the implementation and effectiveness of corrective and preventive actions (CAPA) in the applicable system.
- Identify issues that can be escalated according to the criteria established in the corresponding procedure.
- Implement the continuous improvement of the Quality System through the periodic management review evaluating the results of the internal audits, deviations, CAPA, change controls and others.
- Notify about quality problems that may affect the product, safety and/or compliance according to company's escalation procedures.
- Supervise the metrics of the Quality Management System processes such as Non-conformities, Suppliers, Change Controls, Internal / external audits, among others, identifying process deviations for trend evaluation purposes.
- Coordinate local processes to be compatible with applicable J&J policies, global, sectoral, and regional standards (as applicable).
- Provide orientation and training to employees on Quality and Regulatory compliance.
- Approval and monitoring of suppliers and distributors in accordance with the organization's procedures.
- Coordinate local processes to be compatible with applicable J&J policies, global and regional processes (as applicable).
- Support the Quality Management in the implementation and monitoring of Quality Management Systems elements for LA North Cluster.
- Support all Patient support programs and Diagnostic support programs in compliance with applicable J&J policies, global and regional processes (as applicable).
- Support RRA process (RWE/ Market Research) in terms of vendor qualifications and standards compliance from Local team.
- Support the Quality Management system in the implementation and monitoring of the QMS elements as well as Systems validation, Safety Data sheet handling, JanssenPro solutions, among others in LA North Cluster.
- In the case of absence of the Senior Manager Customer/Commercial Quality LAN, this role assumes the functions related to this position, including the revision and approval of records in the applicable quality system. In case of requiring support from a higher level, this role must contact and wait for instructions from the Director for LATAM or whoever this person designates.
Qualifications / Requirements:
- Advanced Technical Expertise in Quality Assurance
- Advanced Strategic Thinking to Support the Regulatory Plan through Data Analysis, Synthesis, and Integration
- Advanced Strategic Thinking to Support the Regulatory Plan through Data Analysis, Synthesis, and Integration
- Advanced Customer-Oriented Mentality with Staff of Internal and External Interest through Interactions that Add Value
- Advanced Influence, Negotiation, and Strong Verbal and Written Communication Skills
- Advanced Innovation, Challenge, and Adaptation to Change
- Advanced Organization, Planning, and Coordination of Projects
- Bachelor Degree in Health Sciences and / or Chemistry: preferred in the pharmaceutical area, with work experience in the pharmaceutical / biotechnology industry with extensive experience in quality assurance, process methodology.
- Advanced English Level
- Minimum 5 years of experience in Quality Systems
