Commercial Quality Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Position Summary:

The Commercial Quality Specialist is a key contributor to ensuring robust compliant and customer-focused quality operations across the APAC region (excluding Japan). This role serves as an important link between operational execution and strategic quality initiatives driving excellence in field action management field service quality support supplier and distributor oversight and continuous improvement of the Commercial Quality System.

The position requires strong cross-functional collaboration and the ability to influence without direct authority partnering closely with internal stakeholders and external partners to uphold regulatory compliance and meeting customer needs. While the role does not include direct people management it demands a high level of accountability problem-solving and leadership in quality-related matters.

Key Responsibilities

Field Action Management

• Lead and coordinate the execution of field actions across the APAC region in compliance with Abiomed Standard Operating Procedures (SOPs) and applicable regulatory requirements.

• Ensure timely communication and reporting of field action activities to internal stakeholders and external partners.

• Ensure timely documentation of field action execution within Abiomeds Quality Management System.

• Monitor effectiveness checks and closure activities to confirm regulatory compliance and safeguard patient safety.

Adverse Event Reporting

• Ensure timely reporting of adverse events to local health authorities.

• Ensure timely documentation of adverse event reporting within Abiomeds Quality Management System.

• Provide support to the distributor in fulfilling adverse event reporting requirements to local health authorities.

Field Service Quality Support

• Partner with Technical Service team to ensure field and depot servicing activities adhere to Abiomed SOPs and local regulatory standards.

Distributor and Supplier Quality Oversight

• Assist in distributor and supplier qualification ongoing monitoring and performance evaluations.

• Collaborate with Procurement and Supplier Quality teams to address non-conformances implement corrective actions and drive continuous improvement.

• Contribute to distributor and supplier audits ensuring compliance with Johnson & Johnson standards and relevant regulations.

Commercial Quality System Continuous Improvement

• Identify opportunities for process improvement within the Commercial Quality System to optimize efficiency and compliance.

• Support key quality processes including change control non-conformance (NC) management corrective and preventive actions (CAPA) and risk management for local operations.

• Participate in the development review and refinement of SOPs and quality documentation.

Market-Facing Quality Support

• Serve as a quality liaison for commercial operations ensuring market requirements and regulatory obligations are consistently met.

• Collaborate with Supply Chain and Regulatory Affairs teams to resolve quality issues impacting import and supply.

• Provide support during internal and external audits and inspections as required.

Training & Development

• Maintain current knowledge of applicable regulations Johnson & Johnson policies and Abiomed procedures.

• Engage in continuous professional development and actively contribute to team knowledge sharing and capability building.

Qualifications

Education

• Required: Bachelors degree in science engineering or related discipline.

• Preferred: Masters degree in business quality management or regulatory affairs.

Experience

• Minimum 35 years of experience in quality regulatory or compliance roles within medical device or pharmaceutical industries.

• Proven experience in field actions adverse event reporting field service quality support supplier quality and quality system improvement.

• Familiarity with SAP and Quality IT Systems is preferred.

• Experience working in multi-country multicultural environments and with healthcare regulatory bodies (e.g. FDA TGA HSA).

Skills

• Strong analytical and strategic thinking with the ability to manage both tactical and high-level tasks.

• Excellent collaboration and influence management skills across functions and geographies.

• Ability to build consensus and drive decisions without direct authority.

Required Skills:

Preferred Skills: