CQ Lead, Malaysia

Johnson & Johnson Sdn. Bhd.; Selangor; On-site; MYR 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Sdn. Bhd. in Malaysia is recruiting a CQ Lead, Malaysia, based in Petaling Jaya. You will manage the site quality system, oversee supplier and distributor quality, and ensure compliance with DS policies and local regulations.

The role covers handling adverse events, audits, change control, complaints, CAPA, product release, and documentation. You will lead cross-functional teams to sustain quality, drive continuous improvement, and support regulatory inspections.

Qualifications

• Requires knowledge and understanding of industry and regulatory standards.
• Experience in training, supervising and risk-based approach.
• Good interpersonal and communication skills.
• Ability to plan and manage inspection activities.
• Demonstrated ability to deliver results.

Responsibilities

• Oversee site quality management system activities including change control and supplier oversight.
• Ensure adverse event reporting to health authorities where required.
• Lead inspection management and audit readiness.
• Coordinate NC/CAPA management and trending metrics.
• Support product release, returns and related quality processes.

Skills

Quality systems

Regulatory knowledge

Audit readiness

Change management

Communication skills

Inspection management

CAPA

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Job Description:

DePuy Synthes is recruiting for a CQ Lead, Malaysia,locatedin Petaling Jaya, Malaysia.

This role is responsible for the site management and execution of Quality Systemsestablishment, implementation and maintenance for Malaysia, including overseeingof Suppliers and Distributors, in order to meet the applicable regulatory and customerrequirements and DePuy Synthes (DS) policies and standards.

Essential Job Duties and Responsibilities

Site quality management system activities:
1. Acquisition and divestiture:

• Provides quality support for acquisition and divestiture activities, includingchange control.

2. Adverse event and/or Health Authority reporting (where applicable)

• Responsible to report adverse events/product quality issues are reported tothe health authority in the site if required by local regulation, and ensuresrobust processes are in place for timely reporting and closure.

3. Audit Readiness, including Inspection management:

• Ensures compliance and audit-readiness of site to DS Quality Policy Standardsand applicable local regulatory requirements (i.e. GDP and GDPMD).Lead as site SME for inspection management by coordinating activities relatedto pre- and post- audit including providing briefing and guidance to all crossfunctional team, managing audit arrangement and lead in audit response toauditor.

4. Change Control

• Lead for site’s change control management. Responsible to ensure process isfollowed and records are managed in a timely manner with proper impactassessment, monitoring are taken. Monitors related metrics and initiatesactions for improvement

5. Complaints management

• Lead the end to end complaint management for the site. Responsible toprepare and sign customer resolution letters when requested by complainant.Monitors trends, related metrics and initiates actions for improvement.

6. Combination product

• Ensures local regulations and DS standards related to combination productsare met.

7. Document control

• Support and ensure site compliance to document lifecycle management.

8. Labeling and Packaging

• Provides Quality support (such as updating quality agreements, issuingredressing instructions) in repack/relabel operation to ensure compliance tointernal procedures and local regulations. Monitors related metrics andinitiates actions for improvement.

9. NC CAPA Management

• Lead for site’s NC/CAPA management. Responsible to ensure process isfollowed and records are managed in a timely manner with properinvestigation, root cause analysis and corrective and preventive action taken.Monitors related metrics and initiates actions for improvement.

10. New Product Introduction and Product Discontinuation

• To provide Quality support during new product launch and establish any newquality processes to support commercial launch if applicable.
• To work with stakeholders to manage activities related to productdiscontinuation to ensure compliance to internal and external requirements.

11. Escalation and Field actions

• Oversee the management of Escalations, Field Action, Mock Field Action andStop shipment applicable to the site.

12. Product Release and Product Returns

• Supports activities related to product inspection and release, temperatureexcursions and trade returns according to product specifications and internalprocedures.

13. Purchasing Control, including POLO

• Support activities related to purchasing controls. Ensures suppliers/POLO areappropriately qualified, monitored and in compliance to up-to-date QualityAgreements, where applicable.

14. QSMR and metrics reporting

• Coordinates key quality metrics reporting. This includes Non-conformance,CAPA, Complaints, Change Control, Audit Actions tracking and monitoring asper timelines.

15. Quality Manual

• Responsible to establish and maintain site’s Quality Manual.

16. Records retention

• Provide guidance to LOCs on record retention process in collaboration withrecords coordinator.

17. Training Management

• Support and ensure site compliance to GxP training plan for quality systemelements covered by the site’s quality manual. This role is also responsible forthe metrics, communications, reports and non-conformance related to theseareas.

Distributor quality oversight

1. This role is responsible for the execution and compliance of Quality ManagementSystems elements applicable to the Distributor as required per DS standards andapplicable local regulatory regulation, including: product release and returns,handling of storage, temperature controls, traceability, repack relabels, loaner setmanagement, and NC/CAPAs.

2. This role is also responsible for purchasing control activities related to the
distributor such as qualification, audits, and monitoring of distributor quality KPIs.

Required Qualification and Core Competencies for the role:

Requires knowledge and understanding of industry and regulatory standards, andoverall DS Quality Systems. Needs experience in training, supervising and risk-basedapproach in execution. With good interpersonal and communication skills who caninterface and influence stakeholders. Demonstrated ability to plan and manageinspection activities related to assigned responsibilities. Skill in multiple computerbased tools. Can deliver results.

1. Good interpersonal and communication skills, with a collaborative approach tostakeholders.
2. Analytical and problem-solving capabilities
3. Acumen for prioritization and decision making
4. Demonstrate change management and project management ability

5. Knowledge and application of quality and regulatory requirements.

Johnson & Johnson announced plans to separate ourOrthopaedicsbusiness toestablisha standaloneorthopaedicscompany, operating as DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Johnson & Johnsonisan Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that isinclusiveofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, external applicants please contact us viahttps://www.jnj.com/contact-us/careers, internal employees contactAskGSto be directed to your accommodation resource.

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Required Skills:

Preferred Skills: