Job 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 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.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Petaling Jaya, Selangor, Malaysia

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 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 humanity. Learn more at https://www.jnj.com

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 processes,ensuringtimelyinvestigations, 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.

• Establish,maintain, 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

• Bachelor’s degree in Science, Engineering, Pharmacy, Data Science, or relatedfieldwith 4–5 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.

Learn more at https://www.jnj.com/innovative-medicine

Required Skills:

Big Data Management, Efficiency Analysis, Stakeholder Engagement, Stakeholder Management, Subject Matter Experts (SME) Collaboration

Preferred Skills:

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