Senior Commercial Quality Executive

3 weeks ago

Jakarta, Indonesia Johnson & Johnson Full time

**SENIOR COMMERCIAL QUALITY EXECUTIVE (MedTech)**

Location: Jakarta (office and warehouse)

J&J MedTech Indonesia is looking for a Senior Commercial Quality Executive to be based in Jakarta, splitting their time as necessary between our warehouse (in Kelapa Gading) and the main office (SCBD).

As the Senior Commercial Quality Executive, you will be responsible for E2E support on hospital process e.g., NPD/NPI, promotion, repack/relabel, NC/CAPA, Escalation, FA/SS, Change Control, Warehouse (DC/3PL/Distributor plus), complaint, product distribution, disposition, and process improvement.
You will also be J&J MedTech's Technical Responsible Person (PJT - Penanggung Jawab Teknis) to authorize and responsible to manage and maintain the activities in the warehouse of J&J Medical Devices and distribution system and ensure the safety, quality and benefit of the medical devices by meeting the requirement of GDP (CDAKB) MoH Regulation. This is based on the Ministry of Health's Regulation No. 4 year 2014 about Good Distribution Practice for Medical Devices, and Medical Devices distributor.

You will also:
**Manage and maintain the Complaint Vigilance, Stop Shipment, Field Action including the following**:

- Own and oversee the day-to-day running of the Complaint Management System
- E2E support execution and follow-up all product quality holds and field actions.
- Participate in coordination of field actions, liaising with regulators, sales and field sales engineers, customer service and warehouse personnel as appropriate to all activities are executed accordingly and within the stipulated timeframes.

**Manage and maintain the Change Control and Document Management Systems and processes, including the following**:

- Maintain and manage the associated workflows for new/revised documents and changes.
- Manage the requests for, issuance and subsequent archival of documents and changes
- Manage access rights for the system to access document system.
- Assess the criticality of changes and track the closure of tasks associated with the change.

**Manage and maintain the Audit and inspection, including the following**:

- Own and /or oversee the day-to-day running of the Audit.
- Plan / participate in the audits for the site
- Follow up finding reports for the audits and review the actions required
- Raise/follow up and to closure of QI and CAPAs generated for internal Audits

**Support Management Review**
- Prepare the related metrics e.g., complaint and adverse event trending, CAPA status, NCR closure) for Review and track all after review.
- Prepare metrics for Management Review and track all after review actions to closure

**Qualifications**:
**Required Qualification**
- Minimum bachelor’s or master’s degree in Life Sciences, Engineering or health-related discipline.
- Minimum of 5 years in the pharmaceutical, healthcare industry.
- Certified lead auditor or prior auditing experience in a regulated environment.
- Experience with GDP of Medical Devices, ISO 13485 or equivalent quality standard program preferred.
- Strong ability to influence other decision that will benefit the company as a whole.
- Demonstrated ability on project management, analytical and process-oriented.

**Core Competencies for the role**
- Sufficient knowledge on GDP of Medical Devices Regulation, J&J Quality and Technical Standards, Commercial
- Quality SOPs, Sector/Regional procedures, GxPs, regulations, and other quality systems and guidelines.
- Must be able to develop and maintain excellent working relationships, work successfully within a teamenvironment and as an individual contributor.
- Leadership, collaboration, and interpersonal skills
- Communication, presentation and management skills.
- Proactive team player, able to take charge and follow-through. Achievement-oriented with a high degree of
- Flexibility and ability to adapt to a changing environment.
- Warehouse and Operational Activities.

**Summary of Experience and Required/Preferred Skills**
- Prepare training materials, organize and conduct quality systems training as required.
- Train people in process improvement methodologies, techniques, tools, root cause analysis, quality language etc. to improve processes and improve business results.
- Enforce the requirements of the quality systems ensuring simplicity, standardization and education across the functions, requirements are effectively established and executed throughout the organization in accordance with Good Distribution Practices, Medical Device requirements and J&J policies.

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