Associate Manager, Quality System, Sea

5 months ago

Jakarta, Indonesia Johnson & Johnson Full time

Johnson & Johnson is seeking an experienced and ambitious Associate Manager, Quality System to join our Commercial Quality team in MedTech Southeast Asia. This is an exceptional opportunity to contribute to the development and implementation of world-class quality systems in a leading healthcare company. As an Associate Manager, you will play a key role in ensuring flawless quality assurance and compliance with regulatory requirements.

Key Responsibilities:
1. Quality Metrics Reporting and Performance Review and trend if any significant or systemic issues observed in SEA Cluster

2. E2E Document Management to assist SEA LOCs for any support required.

3. Training strategy and implementation to assist LOCs for any support required

4. Internal Audit Program strategy and implementation including scheduling, execution of the audit, coordinating on qualified auditors pool and trending of observations for any significant or systemic issues to be addressed.

5. Assist in strategy and deployment and execution of Quality Policies, MedTech HMD and/or CQ SOPs as applicable. Work closely with SEA LOCs in the region and help maintain related standards and policies and provide input to global standards and processes.

6. Quality System Management Review, Quality Planning, CAPA, Failure Investigation, Escalation, Internal Audit, Trending and Risk Management within SEA Cluster.

7. Participate in APAC MedTech Quality system meeting and/or Community of Practice (COP) activities as SEA CQ representative and ensure on time deployment MedTech HMD and CQ SOP and cascade down the global/regional program/initiatives.

8. Serves as one of the SEA SME on quality system tools e.g NC/CAPA, audit management, change control, Document Repository system and Learning Management System.

9. Actively support LOCs on E2E J&J enterprise audit process.

10. Actively engage in quality system management activities in terms of quality system compliance, inspection management, business solution innovation, and customer facing quality initiatives.

11. Support Asia Pacific CQ Strategy and Objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.

**Qualifications**:

- Degree in Engineering/Science or associated relevant technical/Quality field
- Minimum of 5 years of experience in quality assurance within the healthcare or pharmaceutical industry
- Broad-based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance
- Solid understanding of FDA regulations and ISO quality standards
- Experience in audit and health authority inspection management
- Internal Auditor qualification in quality management system, preferably Lead Auditor qualification for ISO13485:2016
- Experience and proficiency in quality management software and tools
- Demonstrate project management skills.
- Proficiency in analytical tools, problem solving capability and customer oriented mentality
- Competence in prioritization and decision making.
- Proven track record of successfully implementing quality system improvements
- Digital savvy with sophisticated data visualization and analytical skills.
- Excellent communication and interpersonal and communication skills in fast paced environment

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