J&J Family of Companies [존슨앤드존슨] Senior Manager CLS Quality & Compliance North Asia in Yongsan-gu, South Korea

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

  1. 포지션: Senior Manager CLS Quality & Compliance North Asia

  2. 근무지: 서울시 용산구

[Summary]

The Lead North Asia CLS Q&C is accountable and responsible to manage the execution and compliance of Quality Management Systems elements applicable to Johnson & Johnson distribution centers (including Loan Kit Operations) in North Asia that receive, pick, pack, store, inspect, and deliver finished goods to Customers, Retailers, Wholesalers, and Distributors.

The Lead North Asia CLS Q&C serves a single point of contact to North Asia CLS Lead on Distribution Quality related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues.

The Lead North Asia CLS Q&C ensure that products distributed by Johnson & Johnson in North Asia are distributed in accordance with Johnson & Johnson Standards, applicable ISO Standards and regulatory requirements.

The lead North Asia CLS Q&C ensure that Johnson & Johnson storage facilities are designed, constructed, qualified and maintained in accordance with Johnson & Johnson standards, product requirements, applicable ISO standards and regulatory requirements.

The lead North Asia CLS Q&C is responsible to support CLS Operation on matters related to the distribution of Johnson & Johnson products, including but not limited to providing Quality input and oversight of distribution network changes

The lead of North Asia CLS Q&C works with the Business Quality Organization for Medical Devices, Pharmaceutical and Consumer within North Asia, to define and implement CLS Quality strategies and services, and drive timely resolution of Quality Issues relating to the distribution of Johnson & Johnson products.

The Lead North Asia CLS Q&C optimizes quality systems and processes and ensure alignment with the worldwide business, the quality vision, and provide a measurable impact to quality, cost, and customer value. Identifies opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and lead improvement opportunities and problem solutions. Understands current and emerging regulations and the impact to quality and distribution practices.

[Responsibilities]

The Lead North Asia CLS Q&C plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following essential duties and responsibilities personally or through subordinates:

1) Distribution and Inventory Management Process

  • Accountable for overseeing the controls and quality standards for all distribution and inventory management activities.

  • Accountable for robust product disposition procedures and the quality oversight of all product quality holds and field actions impacting the distribution centers.

  • Responsible for evaluating the company’s quality and distribution process capabilities against company and industry standards and regulatory expectations.

  • Accountable for adherence to temperature control and monitoring requirements within facility and during transportation.

  • Accountable for validation of cold chain facilities and validation of cold chain and controlledambient pack out and transportation lanes.

  • Accountable for accurate and timely communication of temperature control excursions occurring within DC to appropriate partner.

  • Accountable for the investigation of temperature control excursions and subsequent remediation activities.

  • Accountable for implementation of processes for labeling activities at appointed distribution centers

2) Quality Management Systems.

  • Provide support to Business Quality for the implementation and improvement of Quality Management Systems

  • Responsible for ensuring the appropriate handling of distribution related customer complaints including track and trend and mitigation of quality related issues for medical DC’s.

  • Responsible for overseeing the controls and quality standards of Quality system validation including CAPA and NC

  • Accountable for management of Quality systems, including CAPA process and systems document management, change control, training management, preventive maintenance systems, Quality agreements

3) Compliance

  • Ensure CLS related standards are effectively implemented, and on-going compliance by CLS Operations

  • Accountable for the successful management of Health Authority inspections e.g: local FDA) as well as other logistics and transportation related inspections in Johnson & Johnson distribution Centers

  • Responsible for proactive identification and mitigation of compliance risk at J&J Internal DC’s through QSCAN, internal audits and other compliance programs.

  • Responsible to ensure the readiness of J&J Internal DC for JJRC audit including ensure the timely closure of any audit action plan

  • Support Business Quality for any of JJRC audit at marketing company relating to quality and compliance activities at distribution centers such as supplier audit report, quality agreement, etc.

  • Accountable and responsible for timely and accurate metrics and reports as J&J policies.

A. Metric evaluation and reporting in CURVE

B. CURVE entry updates

C. Execution of Distribution management reviews.

  • Establish appropriate goals and objectives and business measurements for team members

4) Distribution Supplier Quality Management

  • Accountable for qualification of distribution, logistics and transportation.

  • Accountable for Quality Management of distribution, logistics and transportation.

  • Supplier Management:

A. Establish & maintain Quality Agreements with CLS suppliers e.g. 3PL’s & transporter service providers & CLS related applicable facilities suppliers e.g. calibration & maintenance, pest control & cleaning agencies

B. Manage on-going Quality relationship with CLS suppliers (e.g. 3PL & transporters) & CLS related C. Facilities suppliers, including CC’s, NCR’s, & CAPA’s.

D. Conduct or support audits of CLS suppliers according to Business Quality requirements and purchasing control standard

F. Provide quality support for CLS related supplier engagement & disengagement activities

5) Management

  • Responsible for carrying out managerial responsibilities in accordance with the organization’s policies and applicable laws, including interviewing, hiring and training employees, planning, assigning and directing work , appraising performance, addressing complaints and resolving problems.

  • Responsible for providing Quality input and oversight on distribution network changes.

6) Cluster specific responsibilities

  • Responsible for providing Quality input and oversight on distribution network changes.

[Requirements]

1) The Lead North Asia CLS Q&C is required to have the following essential knowledges and skills:

  • Company Credo Values

  • Strong knowledge of cGMPs, JNJ Standard procedures and other Quality Systems and Guidelines of cross sectors

  • Strong knowledge of JNJ Quality Management system and local regulations related to the scope of CLS

  • Knowledge of the quality Management system as per ISO9001 and ISO13485

  • Knowledge of the Local regulatory requirements related to distribution of products

  • Good knowledge of the distribution practices

  • Knowledge of the process validation and qualifications

2) The lead North Asia CLS Q&C Is required to have the following Core competencies for this role

  • Forge Strong external and internal collaboration across levels within CLS, Sector BQ, & Service providers.

  • Take ownership for talent acquisition, performance and development of self and others.

  • Engage in transparent and constructive conversations.

  • Empower people and act with speed agility and accountability.

  • Maintain highest standards of ethics, quality, compliance and act in accordance with quality & compliance core objective.

  • Make decisions and take actions based on enterprise wide mindset and add value across organization.

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[이메일 문의]

recruitment-jnj@ITS.JNJ.COM

Qualifications

see above

Primary Location

South Korea-Seoul-Yongsan-gu

Organization

Johnson & Johnson Medical Korea (Ltd.) (7225)

Job Function

Compliance

Requisition ID

1700182785W