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Senior Executive Commercial Quality

3 months ago

Singapore J&J Family of Companies Full time

Senior Executive Commercial Quality W

Description

Johnson & Johnson is currently seeking a Commercial Quality Senior Executive to join our team located in Ascent, Singapore. 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

Johnson & Johnson (J&J) MedTech is a provider of medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease, and improve the quality of life of patients and consumers. 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 the Commercial Quality Manager, MedTech Singapore, Malaysia & Philippines. This role is responsible for the site management and execution of Quality Systems establishment, implementation and maintenance for Singapore, including overseeing of 3rd party logistics, and service center in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards.

Responsibilities:

Manage the end-to-end MedTech product complaints and adverse event reporting for the site in a timely manner and monitor related trends. Manage the overall activities related to escalations, field action, and stop shipment applicable to the site. Lead audit readiness activities for external inspections and internal audits for the site, including audit response. Coordinates Quality System Management Review meetings and key quality metrics reporting, which includes Non-conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines. Support and ensure site compliance to GxP training plan for quality system elements covered by the site's quality manual. Oversee activities related to Supplier/Distributor lifecycle management (qualification, audits and disengagement).

Supports the following operational activities related to MedTech segment with cross functional stakeholders:

  • New Product introduction
  • Product Change management
  • Labeling and Packaging
  • Product discontinuation
  • Change control
  • Document control
  • Non-conformances and CAPA
  • Product inspection and release
  • Temperature excursion
  • Trade return disposition
  • Installation and Servicing quality oversight
  • Support projects and duties as assigned by manager.

Qualifications

  • Bachelor's degree or equivalent in Science, Biology, or related discipline.
  • Minimum 4 to 5 years of experience as a quality assurance personnel or related role.
  • Proficiency in written and spoken English.
  • Requires knowledge and understanding of industry and regulatory standards and overall quality management system (QMS).
  • Good interpersonal and communication skills that fosters partnership and influences diverse stakeholders.
  • Proficiency in common software's such as Excel, Word, PowerPoint. Ability to learn and master the various systems used manage activities and data related to Johnson and Johnson QMS.
  • Agile and able to work independently and achieve objectives related to assigned responsibilities.
  • A strong team player with outstanding interpersonal, communication & presentation skills.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Primary Location Asia Pacific-Singapore-Singapore-Singapore

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

Job Function Quality Assurance

Req ID: W