Commercial Quality Senior Executive

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are ourexpertisein Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs oftomorrow andprofoundlyimpacthealth for more at

Job Responsibilities

• Lead site Quality Management System (QMS) establishment implementation maintenance and continuous improvement for Malaysia & Brunei operations including distributioncentres.

• Lead and oversee Change Control Non-Conformance (NC) CAPA and Complaint Management processesensuringtimelyinvestigations impact/risk assessments root cause analysis effectiveness trend analysis and continuous improvement.

• Manage quality oversight for labelling packaging repack/relabel operations controlled substances and combination products to ensure regulatory and J&J compliance.

• Provide quality support for new product introductions product discontinuations product release temperature excursions field actions and trade returns.

• Act as Site Quality SME for audit readiness and inspection management including regulatory inspections and internal audits.

• Establishmaintain and govern site quality documentation including Quality Manual document control records retention and training compliance.

• Lead andconductQualitySystemManagement Review and metrics reporting.

• Lead supplier/distributor qualification and monitoringactivities related topurchasingcontrol.

• Provide distributor quality oversight to ensure compliance with J&J standards and local regulations across product release/returns storage and handling temperature control traceability repack/relabel activities controlled substances and NC/CAPA management.

• Serve as Subject Matter Expert for assignedcentralisedquality systems across Southeast Asia & India supporting regional quality initiatives and projectsas assigned.

Job Requirements

• Bachelors degree in Science Engineering Pharmacy Data Science or relatedfieldwith 45 years of relevant industry experience.

• Strong knowledge of regulatory requirements industry standards and Quality Management Systems (QMS) preferably within a pharmaceutical environment.

• Proven experience in audit readiness inspection management risk-based quality execution and training activities.

• Strong analytical problem-solving and root-cause analysis skills with a continuous improvementapproach.

• Excellent verbal and written communication skills with the ability to influence cross-functional and externalpartners.

• Highproficiencyin MS Office SAP and digital tools; experience with Power BI Power Automate and Power Apps is preferred.

• Ability to work independently in a matrix multinational environment while managing multiple priorities and tight deadlines.

• High integrity strong attention to detail adaptability and resilience in a fast-paced highly regulated environment.

About Innovative Medicine

Ourexpertisein 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.

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