Commercial Quality Specialist, India

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Job title: Commercial Quality Specialist India

Overall purpose of job:

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 role reports solid line to Commercial Quality Senior Manager MedTech SEA and India Cluster EP.

This role is responsible for the site management and execution of Quality Systems establishment implementation and maintenance for India including overseeing of 3PLs and Distributors in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards.

Key responsibilities:

Site quality management system activities:

1. Acquisition and divestiture:

Provides quality support for acquisition and divestiture activities including change control.

2. Adverse event and/or Health Authority reporting

Responsible to report adverse events/product quality issues are reported to the health authority in

the site if required by local regulation and ensures robust processes are in place for timely reporting and closure.

3. Audit Readiness including Inspection management:

Ensures compliance and audit-readiness of site to J&J Quality Policy Standards and applicable local regulatory requirements (i.e. GDPMDS).

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.

4. Change Control

Lead for sites 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.

5. 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.

6. Document control

Support and ensure site compliance to document lifecycle management

7. 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.

8. NC CAPA Management

Lead for sites 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.

9. 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.

To work with stakeholders to manage activities related to product discontinuation to ensure compliance to internal and external requirements

10. Escalation and Field actions

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

11. Product Release and Product Returns

Work closely with 3PL/Distributor to support activities related to product inspection and release temperature excursions and trade returns according to product specifications and internal procedures.

12. Purchasing Control including POLO

Manage activities related to purchasing controls. Ensures suppliers/distributors/POLO are appropriately qualified monitored and in compliance to up-to-date Quality Agreements where applicable

13. 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.

14. Quality Manual

Responsible to establish and maintain sites Quality Manual

15. Records retention

Provide guidance to LOCs on record retention process in collaboration with records coordinator

16. Training Management

Support and ensure site compliance to GxP training plan for quality system elements covered by the sites quality manual. This role is also responsible for the metrics communications reports and nonconformance related to these areas.

Required Qualification and Core Competencies for the role:

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.

1. Good interpersonal and communication skills with a collaborative approach to stakeholders.

2. Analytical and problem solving capabilities

3. Acumen for prioritization and decision making

4. Demonstrate change management and project management ability.

5. Knowledge and application of quality and regulatory requirements

Job location:

India

Required Skills:

Preferred Skills: