Quality Systems Manager, APAC Commercial Quality - 2406203040W

Description

Johnson & Johnson is currently seeking a Quality Systems Manager, APAC Commercial Quality to join our Commercial Quality team located in APAC.

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/ .

Responsibilities

• Harmonize the Asia Pacific CQ Innovative Medicine Quality System in alignment with global strategy, execute associated systems and standards, and establish programs and initiatives to advance compliance. This includes creating the quality framework and related quality system elements such as Quality Metrics, E2E Document Management, Training Implementation, CAPA Review Board, Quality System Management Review, Internal Audits, and other key quality areas.

• Drive process excellence by leveraging digital technologies and data analytics to gain insights from Quality Systems, adding value to customer experience and supporting business and organizational growth. In addition, enhance customer experience through data-driven insights by transforming the complaints management process to uncover insights and perform trend analysis, improving the customer experience within the Asia Pacific organization.

• Partner with CQ teams in local operating companies (LOCs) to identify and gather input on potential risks, confirm their impact, and support appropriate actions to ensure risks are effectively addressed.

This role is open to any candidate in Asia Pacific.

1. Asia Pacific CQ Innovative Medicine Quality System Harmonization

• Global Procedural Documents Deployment and Life Cycle Management

o Manage end-to-end impacted global procedural new/update to perform Impact Assessment, Training applicability and assignment, update relevant documents impacted by the change

o Maintains and update Intra-Quality Agreement

• Quality Metrics and Performance Reviews

• Owns APAC data metrics compilation, analysis and commentary

• Represents APAC in global council (Innovative Medicine) and other metrics forums

• Monitors CQ metrics through review board meetings

• Establish programs and initiatives to advance compliance, including:

• Quality Metrics

• End-to-End Document Management

• Training Implementation

• CAPA Review Board

• Quality System Management Review

• Internal Audits

• Other key quality areas

2. Quality Systems Application Maintenance

• SME for COMET NC/CAPA, Change Control and Audit Module, SUMMIT Training System, Tru Vault Document Management

• Participates in global forums and improvement initiatives.

3. Risk Management

• Gather input, confirm the potential risk, elevate and support with appropriate actions to ensure risks are being addressed

• Demonstrate good knowledge of business impact of compliance issues and risk management.

4. Process Excellence and Digital Initiatives

• Partner with appropriate functions to identify, develop, validate and deploy innovative technology and process solutions and applications to deliver the quality system of the future throughout CQ Asia Pacific

• Support to identify opportunities for utilization of digital tools and executes to gain efficiencies.

5. Product Complaint Management

• Perform trend analysis and uncover insights to enhance customer experience through product complaints management process within the Asia Pacific organization.

Qualifications

• Degree in Engineering/Science or associated relevant technical/Quality discipline

• At least 6-10 years of Quality System-related experience in a regulated medical industry (Pharmaceuticals, Medical Devices).

• Broad-based technical knowledge and skills in business areas such as Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory and Quality Compliance and Technology

• Experience of the business environment outside of the quality organization (e.g., manufacturing, product / process development, customer service, etc.). Ability to communicate technical language into business language.

• A strong technical understanding of data analytics tools and technologies, ability to analyze complex data and interrelations to derive meaningful outcomes to support business needs

• Proficiency in analytical tools, dashboards (such as Tableau, or PowerBI) and experience in applying emerging digital technologies

• Great leadership with strong collaboration among the stakeholders and effective communication

• Teambuilding and development capabilities

• Good Strategic thinking

• Analytical and process-oriented mindset

• Displays initiative and able to independently create and deliver

Primary Location Asia Pacific-Singapore-Singapore-Singapore

Other Locations Asia Pacific-Japan, Asia Pacific-Taiwan, Asia Pacific-Australia, Asia Pacific-Philippines, Asia Pacific-India, Asia Pacific-China, Asia Pacific-Indonesia, Asia Pacific-Thailand, Asia Pacific-South Korea, Asia Pacific-New Zealand, Asia Pacific-Malaysia

Organization Johnson & Johnson International (Singapore) Pte Ltd (8438)

Job Function Customer/Commercial Quality

Req ID: 2406203040W