Commercial Quality Associate Manager - Malaysia, Brunei and Indonesia

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:
Jakarta Selatan, Jakarta Raya, Indonesia, Petaling Jaya, Selangor, Malaysia

Job Description:

Commercial Quality Associate Manager:

Johnson & Johnson (J&J) Innovative Medicine is a provider of pharmaceutical products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease, and improve the quality of life of patients and consumers. The Johnson & Johnson Commercial Quality department provides quality oversight and support to the local operating companies in the areas of strategy and planning, quality system oversight, compliance reporting, portfolio and product lifecycle management, product supply, and distribution.

This role reports directly to the Head of Commercial Quality, India & Southeast Asia (SEA), and serves as a key quality partner to business and cross-functional stakeholders across Malaysia, Brunei and Indonesia.

The Commercial Quality Associate Manager provides quality leadership and oversight for the establishment, implementation, maintenance and continuous improvement of Quality Systems for Johnson & Johnson Innovative Medicine in Malaysia, Brunei and Indonesia, including oversight of distributors. The role ensures compliance with applicable regulatory requirements and J&J policies and standards, leads quality risk management and inspection readiness, and collaborates across functions to protect patients, product quality and supply continuity. In addition, the role serves as the Subject Matter Expert (SME) for the NC/CAPA quality system across Southeast Asia & India and may lead other centralized quality system elements as assigned.

Essential Job Duties and Responsibilities:

Site quality management system activities:

- Quality leadership and governance: Lead the LOC quality agenda for Malaysia, Brunei and Indonesia, translate enterprise and cluster quality strategy into market priorities, provide independent quality judgment, and escalate significant compliance or product risks appropriately.

- Quality Management System: Own and maintain an effective, inspection-ready LOC QMS, including the Quality Manual, procedures, records, training and document lifecycle controls; identify systemic gaps and lead sustainable improvements.

- Inspection and audit readiness: Lead readiness for Health Authority inspections and internal audits, coordinate cross-functional preparation, act as site quality representative or SME, oversee responses and commitments, and ensure timely, effective closure of observations.

- NC/CAPA and quality risk management: Serve as Cluster SME for NC/CAPA; coach record owners on investigations, root-cause analysis and action effectiveness; lead impact assessments and product risk management; monitor trends and drive prevention of recurrence.

- Change control and regulatory compliance: Provide quality oversight for changes, acquisitions, divestitures and new or revised regulatory requirements; ensure robust impact assessment, implementation and effectiveness monitoring; lead the Regulatory Exchange forum as assigned.

- Product quality events and Health Authority reporting: Oversee complaints, product quality issues, adverse-event interfaces, escalations, field actions, mock field actions and stop shipments; ensure timely assessment, reporting, communication and closure in accordance with local regulations and J&J requirements.

- Product lifecycle and supply support: Provide quality leadership for new product introduction, product discontinuation, product release, returns, temperature excursions, repack/relabel activities, combination products and controlled substances; enable compliant supply continuity and launch readiness.

- Supplier and distributor quality: Lead qualification, quality agreements, audits, performance monitoring and risk-based oversight of distributors, logistics providers, and other GxP suppliers; drive remediation, compliance maturity and continuous improvement.

- Quality performance and management review: Lead QSMR inputs and quality performance reviews; analyze metrics, trends and emerging risks; define improvement priorities and communicate clear insights, decisions and actions to LOC and cluster leadership.

- Cross-functional partnership: Partner with Regulatory Affairs, Medical Affairs, Supply Chain, Commercial, Safety and other functions to embed quality compliance and risk management in business decisions, assess end-to-end impact and resolve complex issues with appropriate urgency.

Distributor quality oversight:

- Provide end-to-end quality governance for distributors and distribution centres, ensuring applicable QMS elements—including product release and returns, storage and temperature control, traceability, repack/relabel, controlled substances and NC/CAPA—meet J&J standards and local regulatory requirements.

- Lead risk-based distributor and logistics governance through qualification, quality agreements, audits, performance reviews, KPIs and timely remediation.

- Lead market oversight to strengthen supplier and distributor compliance, proactively manage risks and ensure resilient, compliant supply.

Minimum Qualification:

- Bachelor’s degree in Science, Pharmacy, Engineering or a related field; advanced degree or quality certification preferred.
- 6+ years’ experience in pharmaceutical or another regulated industry, with ownership of quality systems or market quality activities.
- Strong knowledge of GxP/GDP, Health Authority expectations, quality risk management and QMS processes.
- Experience leading audits, inspections, investigations, CAPA, change control, product quality events or supplier oversight.
- Strong analytical, risk-assessment, problem-solving and decision-making skills.
- Excellent communication and stakeholder-influencing skills across all organizational levels.
- Advanced Excel, Power BI and Power Automate skills, with strong data literacy to generate actionable insights.

Other requirements:

- Demonstrates integrity and sound judgment in addressing quality and compliance concerns.
- Works independently, prioritizes effectively and delivers results in a fast-paced, matrixed environment.
- Leads through coaching, capability building and constructive challenge.
- Builds trusted partnerships and influences stakeholders to drive aligned outcomes.

Required Skills:

Preferred Skills:
Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)