Job Description

Johnson & Johnson (J&J) is a provider of pharmaceutical and medical device 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. This role reports solid line to the Head of Commercial Quality and is responsible to lead the quality system compliance and for end-to-end execution of quality activities for the J&J Innovative Medicines Singapore business. These include key processes such as acquisitions, new product introduction, its associated label, artwork and printed material development, incoming inspection of the products, management of distributors, suppliers and indirect material suppliers, complaints and adverse events, quality holds, field notifications, and field actions, as well as product discontinuation and divestitures. This role manages the change control and non-conformance process related to these areas. Key Responsibilities 1. Quality & Compliance Responsibilities

• Ensure compliance of the Quality Management Systems against the company\xe2\x80\x99s Quality policies and local regulatory requirements

• Ensure New Product Introductions, Acquisitions and Divestitures and Product Discontinuations are approved and executed in a timely and compliant manner

• Work closely with 3PL/distributor to manage the review and release of incoming product inspections and temperature data monitoring, and product returns

• Lead the repack/relabel activities to ensure compliance to applicable standards

• Manage the product quality complaints, escalation, quality hold and field action handling processes. Ensure robust processes are in place for timely execution, reporting and closure.

• Manage the creation and investigation of NCs/CAPAs and monitors the trend and tracking for timely completion, including those related to temperature excursions

• Manage the creation and execution of Change Control and tracking for timely completion

• Lead the implementation of Controlled Substances compliance framework

• Monitor related quality metrics, trends and initiates actions for improvement and coordinate key quality metrics reporting

• Lead activities related to purchasing controls and ensure all third party vendors are appropriately qualified, monitored and in compliance with up-to-date Quality Agreements, where applicable.

• Manage Quality Training Framework administration process and work with cross functions to ensure that trainings are available and executed on schedule

• Manage Document Management system and ensure all periodic reviews completed in timely manner

2. Quality & Compliance Responsibilities (SEA)

• Coach and support junior members within SEA Commercial Quality organisation to manage end-to-end activities performed within the LOC

• Provide LOC expertise to support and enable SEA regional initiatives

3. Audit Readiness

• Lead as site SME for audit management

• Ensure compliance and audit-readiness to J&J Quality Policy Standards and applicable procedures.

• Execute requirements regarding lifecycle management of GxP documents and records to ensure regulatory compliance and business continuity.

4. Understand and ensure continued compliance to global and local regulatory requirements with respect to assigned responsibilities.

QUALIFICATIONS

1. Bachelor\'s degree or equivalent in Science, Pharmacy or related discipline 2. Minimum 4-5 years of experience in the related field, preferred in pharmaceutical industry. 3. Experience across the elements of a quality organization \xe2\x80\x93 quality systems, regulatory, quality operations and regulatory compliance. Requires knowledge and understanding of industry and regulatory standards. 4. High integrity and ethics 5. Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor. 6. Demonstrate strong critical thinking, analytical, organizational, issue management and decision-making skills 7. Adaptability to work with broad scope and evolving situations in a fast-paced environment. 8. Ability to work in a matrix environment with multiple stakeholders and priorities and influence leadership. 9. Excellent verbal and written communication skills - proficiency in written and oral English is required. 10. Proficiency with Microsoft applications such as Excel, Word, Powerpoint