Shire Jobs

Commercial Quality Executive - 2406193582W

Description

Johnson & Johnson is currently seeking a Commercial Quality Executive to join our team in Manila.

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/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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 solid line to Head of Commercial Quality for Singapore, Malaysia, Indonesia and Philippines.

This role is responsible for the site management and execution of Quality Systems establishment, implementation and maintenance for Johnson & Johnson (Philippines) Inc. including overseeing of local Distribution Centres in order to meet the applicable regulatory and customer requirements and Johnson & Johnson 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, including change control.

2. Audit Readiness, including Inspection management:

• Ensures compliance and audit-readiness of site to J&J Quality Policy Standards and applicable local regulatory requirements

• Lead as site SME for inspection management by coordinating activities related to pre- and post- audit including providing briefing and guidance to all cross functional team,

managing audit arrangement and lead in audit response to auditor.

3. Change Control

• Lead for site’s change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment,

monitoring are taken. Monitors related metrics and initiates actions for improvement.

4. Complaints management

• Lead the end to end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends,

related metrics and initiates actions for improvement.

5. Controlled substance

• Ensure Controlled substance management at the site meets J&J requirements and local regulatory requirement

6. Combination products

• Ensures local regulations and J&J standards related to combination products are 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, issuing redressing instructions) in repack/relabel operation to ensure compliance to

internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.

9. NC CAPA Management

• Lead for site’s NC/CAPA management. Responsible to ensure process is followed and records are managed in a timely manner with proper investigation,

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 new quality processes to support commercial launch if applicable.

11. Escalation and Field actions

• Oversee the management of Escalations, Field Action, Mock Field Action and Stop shipment applicable to the site

12. Product Release and Product Returns

• Supports activities related to product inspection and release, temperature excursions and trade returns according to product specifications and internal procedures.

13. Purchasing Control, including POLO

• Support activities related to purchasing controls. Ensures suppliers/POLO are appropriately qualified, monitored and in compliance to up-to-date Quality Agreements,

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 as per 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 with records coordinator

17. Training Management

• Support and ensure site compliance to GxP training plan for quality system elements covered by the site’s quality manual. This role is also responsible for the metrics,

communications, reports and non-conformance related to these areas.

Distributor quality oversight

1. This role is responsible for the execution and compliance of Quality Management Systems elements applicable to the Distributor as required per J&J standards and

applicable local regulatory regulation, including: product release and returns, handling of storage, temperature controls, traceability, repack relabels, controlled substance,

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.

Qualifications

• Minimally basic Bachelor’s degree in Science, Engineering and Technical subjects with 2-3 years of industry experience.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g MS Office, SAP

• Excellent analytical skill to identify gaps and root causes of issues, and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.

Other requirements

Requires knowledge and understanding of industry and regulatory standards, and overall J&J Quality Systems. Needs experience in training, supervising and risk-based approach in execution. With good interpersonal and communication skills who can interface and influence stakeholders. Demonstrated ability to plan and manage inspection activities related to assigned responsibilities. Skill in multiple computer-based tools. Can deliver results.

Primary Location Asia Pacific-Philippines-National Capital-Manila

Organization Johnson & Johnson (Philippines) Inc. (8385)

Job Function Customer/Commercial Quality

Req ID: 2406193582W