Documents business critical issues in Customer/Commercial Quality and tracks regulatory changes.Applies in-depth knowledge of Customer/Commercial Quality and surfaces policies that may impact organizational objectives.Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system.Completes processes to ensure internal organization's alignment with overall quality priorities.Implements formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.Analyzes complex research and data related to regulatory changes, external trends, and strategy.Contributes to customer handling complaint process, and establishes and maintains Quality System Elements.Coaches more junior colleagues in techniques, processes, and responsibilities.​Understands and applies Johnson Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

The main responsibilities are as following in accordance with execution of the Quality Management Systems and compliance, which involve change control, repack/relabel tracking, complaint handling, and reporting serious adverse events.

Support the implementation and maintenance of the Quality System to ensure awareness and continuous education across the local organization.Coordinate with stakeholders, establish and drive the execution of corrective and preventive actions, ensuring the timely closure of CAPA actions, including those involving 3PL DC.Consolidate and track quality compliance metrics, identify and analyze gaps with targets, recommend initiatives for continuous improvement of quality performance, and enforce compliance.Serve as a subject matter expert and provide training to the country on the quality system, auditing behaviors, complaint vigilance, and process improvement methodologies, techniques, tools, and language to enhance processes and improve business results.Drive the execution of complaint vigilance and pharmacovigilance in the country, ensuring the timely closure of product-related complaint cases and Adverse Event reporting.Ensure the material product control within DC, including stop shipmen, return goods, inbound discrepancy and stop shipmenPartner with Commercial business partners and key stakeholders to deliver on-time NPI, AD, and/or POLO to enable high quality and innovative products / disruptive solution into the market that drive growth.Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunitiesUndertake project assignments from the line manager.Documents business critical issues in Customer/Commercial Quality and tracks regulatory changes.Applies in-depth knowledge of Customer/Commercial Quality and surfaces policies that may impact organizational objectives.Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system.Completes processes to ensure internal organization's alignment with overall quality priorities.Implements formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.Analyzes complex research and data related to regulatory changes, external trends, and strategy.Contributes to customer handling complaint process, and establishes and maintains Quality System Elements.Coaches more junior colleagues in techniques, processes, and responsibilities.​Understands and applies Johnson Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

The main responsibilities are as following in accordance with execution of the Quality Management Systems and compliance, which involve change control, repack/relabel tracking, complaint handling, and reporting serious adverse events.

Support the implementation and maintenance of the Quality System to ensure awareness and continuous education across the local organization.Coordinate with stakeholders, establish and drive the execution of corrective and preventive actions, ensuring the timely closure of CAPA actions, including those involving 3PL DC.Consolidate and track quality compliance metrics, identify and analyze gaps with targets, recommend initiatives for continuous improvement of quality performance, and enforce compliance.Serve as a subject matter expert and provide training to the country on the quality system, auditing behaviors, complaint vigilance, and process improvement methodologies, techniques, tools, and language to enhance processes and improve business results.Drive the execution of complaint vigilance and pharmacovigilance in the country, ensuring the timely closure of product-related complaint cases and Adverse Event reporting.Ensure the material product control within DC, including stop shipmen, return goods, inbound discrepancy and stop shipmenPartner with Commercial business partners and key stakeholders to deliver on-time NPI, AD, and/or POLO to enable high quality and innovative products / disruptive solution into the market that drive growth.Supplier Audit program and ensure inspection readiness and provide strategic focus for quality and compliance by working with appropriate functional areas to identify continuous improvement opportunitiesUndertake project assignments from the line manager.Knowledge of Standards:Good understanding and application of MD/Pharm GDP, ISO 13485, ISO 14971 and other international standards.Industry Experience:At least 4 years of experience in a manufacturing, Quality Control (QC), or Quality Assurance (QA) role.Demonstrated experience in quality or operations functions, particularly in the pharmaceutical or medical devices industry.Educational Background:Bachelor’s degree in science (Life Sciences, Microbiology, etc.) or Engineering is required.Technical Skills:Proficient in Microsoft Office, especially PowerPoint, and capable of utilizing other tools for developing training materials. Familiarity with Power Apps is preferred.Analytical Skills:Strong ability to analyze information and make informed decisions.Language Proficiency:Fluency in English is mandatory.

Core Competencies:

Communication:Strong communication skills to effectively relay information to stakeholders.Work Ethic:Demonstrates a strong work ethic, integrity, and respect in all interactions.Customer Focus:A customer-driven approach, prioritizing the needs of both internal and external customers.Judgment:Exercises good judgment and is capable of adapting to changes in a continuously evolving regulatory environment.Knowledge of Standards:Good understanding and application of MD/Pharm GDP, ISO 13485, ISO 14971 and other international standards.Industry Experience:At least 4 years of experience in a manufacturing, Quality Control (QC), or Quality Assurance (QA) role.Demonstrated experience in quality or operations functions, particularly in the pharmaceutical or medical devices industry.Educational Background:Bachelor’s degree in science (Life Sciences, Microbiology, etc.) or Engineering is required.Technical Skills:Proficient in Microsoft Office, especially PowerPoint, and capable of utilizing other tools for developing training materials. Familiarity with Power Apps is preferred.Analytical Skills:Strong ability to analyze information and make informed decisions.Language Proficiency:Fluency in English is mandatory.

Core Competencies:

Communication:Strong communication skills to effectively relay information to stakeholders.Work Ethic:Demonstrates a strong work ethic, integrity, and respect in all interactions.Customer Focus:A customer-driven approach, prioritizing the needs of both internal and external customers.Judgment:Exercises good judgment and is capable of adapting to changes in a continuously evolving regulatory environment.