Commercial Quality Specialist

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• Perform product quality acceptance management to ensure its effective operation, including related SOP/WIs management, guide and monitor the acceptance process of 3PL logistic warehouses, issues handling arising during product acceptance process and review related records.
• Perform market release activities in accordance with applicable regulations and internal quality requirements.
• Perform returned goods management to ensure its effective operation, including related SOP/WIs management, guide and monitor the activities performed by of 3PL logistic warehouses and review related records.
• Perform product destruction management including onsite supervision, records completion and archiving.
• Perform temperature assessment management, including inbound transportation temperature assessment of imported products, response to customer temperature inquiries, and temperature excursions evaluation.
• Perform product traceability management, including application and maintenance of product E‑code master data, uploading relationship mapping and outbound documents, and updating shipping label information.
• Perform document and records management to ensure regulatory compliance and business continuity.
• Perform distributor qualification administration including agreement signing and archiving, annual qualification documents updating and archiving.
• Perform training management activities, including assignment of GxP and procedural training, monitoring training completion status, maintaining training records, supporting training effectiveness evaluation, and ensuring compliance with training requirements and quality metrics.
• Support internal and external audits, regulatory inspections, and follow-up actions to ensure timely closure of observations.
• Support product quality risk assessment, issue escalation, and mitigation activities.
• Support GxP-related computerized systems and support system upgrades, validation, and process implementation activities.
• Support digitalization initiatives and quality system transformation projects by participating in process optimization, system enhancement, data analysis, automation opportunities identification, and deployment of digital solutions to improve operational efficiency and compliance effectiveness.
• Drive continuous improvement initiatives to enhance quality system effectiveness, operational efficiency, and regulatory compliance.
• Perform other duties as assigned.

• Licensed pharmacist is preferred.
• A bachelor's degree or higher in pharmacy, medicine, biochemistry or a related field is required.
• ≥2 years’ experience in the Pharmaceutical or related industry is preferred, ideally with a mix of Quality and Compliance (GxP), Distribution Warehouse management. Quality and Compliance experience is essential.
• Demonstrates strong written and verbal communication skills in both the local language and English.
• Expert knowledge of Microsoft software and presentation.
• Strategic thinking is required, with a focus on process improvement and optimization.
• Demonstrates strong pharmaceutical products and project management skills, with the ability to manage multiple tasks. Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes. Up-to-date knowledge of relevant pharmaceutical legislation and GxP.
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Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment