Senior Manager Commercial Quality

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
People Leader

All Job Posting Locations:
Singapore, Singapore

Job Description:

The Senior Manager Commercial Quality  is  appointed as Management Representative and is accountable for the oversight and execution of effective Quality Management Systems and compliance at MD&D Medical Device AsiaPac  (RDC) that receive, pick, pack, store, inspect, repack/relabel and deliver finished goods to J&J affiliates market in the AsiaPac, and customers, distributors, healthcare facilities in Singapore market

This role serves a single point of contact to Deliver operation lead on Distribution Quality related matters and liaise with multiple Quality organizations across regions and upstream quality pillars to drive timely resolution of Quality related issues.

This position optimizes quality systems and processes and ensures alignment with the APAC business, applicable regulations and J&J MedTech quality policies, strategic framework, quality vision, and provides a measurable impact to quality, cost, and customer value.

 

The position defines and implements departmental strategies and services as the business expert on quality systems, distribution, and quality management.

The position identifies opportunities to continuously improve quality, cost and time factors, consistent with business objectives.

 The position maintains understanding and awareness of current and emerging regulations and the impact to quality and distribution practices.

This individual plan, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinates.

KEY RESPONSIBILITIES

Quality Management Systems


* Act as a management representative for the RDC QMS


* Accountable for management of Quality systems as per ISO13485:2016 and J&J enterprise and/or MedTech quality standards, integrating existing and new regulations to enable favorable compliance profile with applicable health authority in the region.


* Responsible for conducting Risk management of the warehousing, distribution and repack relabel processes, proactive identification and migration of compliance risk


* Ensure regulatory compliance and quality metrics are met; lead the development and implementation of actions to close metric gaps.


* Develo...