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:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Petaling Jaya, Selangor, MalaysiaJob 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 Responsibilities
Lead site Quality Management System (QMS) establishment, implementation, maintenance, and continuous improvement for Malaysia & Brunei operations, including distribution centres.
Lead and oversee Change Control, Non-Conformance (NC), CAPA, and Complaint Management processes, ensuring timely investigations, 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 and conduct Quality System Management Review and metrics reporting.
Lead supplier/distributor qualification and monitoring activities related to purchasing control.
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 assigned centralised quality systems across Southeast Asia & India, supporting regional quality initiatives and projects as assigned.
Job Requirements
Bachelor’s degree in Science, Engineering, Pharmacy, Data Science, or related field with 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 improvement approach.
Excellent verbal and written communication skills with the ability to influence cross-functional and external partners.
High proficiency in 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
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
Required Skills:
Big Data Management, Efficiency Analysis, Stakeholder Engagement, Stakeholder Management, Subject Matter Experts (SME) CollaborationPreferred 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 EnvironmentSkills Required
- Bachelor's degree in Science, Engineering, Pharmacy, Data Science, or related field
- 4-5 years of relevant industry experience
- Strong knowledge of regulatory requirements and Quality Management Systems (QMS)
- Proven experience in audit readiness and inspection management
- Strong analytical and problem-solving skills
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
