Manager, Commercial Quality

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Johnson & Johnson Medtech is recruiting for a Commercial Quality Manager based in Singapore. This role reports solid line to the Asia Pacific Commercial Quality Director MedTech and is a member of the Country’s Medtech Leadership Teams. The individual is responsible for building and leading MedTech Commercial Quality organization in the country which include market responsibility Singapore, Malaysia and Philippines. This role requires partnership and building of alliances with the in-country Business, Regulatory Affairs, Safety, Legal and Supply Chain teams and external stakeholders to proactively determine risks and compliant solutions to the business growth opportunities in the country. The Commercial Quality (CQ) Head has the overall Quality oversight and responsibility to ensure regulatory compliance of all commercialized products.

Key Responsibilities:
The Commercial Quality Head is responsible for execution of the Quality Management System elements applicable to distribution and commercialisation of products from local new product introduction, product importation, change management, deviations and CAPA reporting, labelling requirements, commercialization, product release, distribution, complaints management and adverse event reporting, Quality reviews, escalations, field action execution, if any, and management of all Health Authority inspections. The role also has Q&C responsibility to ensure that storage and handling facilities that pick, pack, store, inspect and deliver are designed, constructed and maintained in accordance with J&J standards, product requirement and applicable regulatory requirements.

The role, as a Management Representative, provides end-to-end compliance leadership and serve as voice of quality in the local management board, ensuring the local company’s Quality Management system to standards as defined by SEA Quality System. It should prepare and enable the local organization to maintain continued compliance, navigating through the changing local government regulatory requirements.

The Commercial Quality Head will also be responsible for planning & managing local budget, as per alignment with each LOC’s targets. The success in this role will ensure that the Quality community operates as a change agent and demonstrating the Leadership Imperatives.

**Grow**
- Collaborate with QS teams to leverage knowledge to drive agility and organisational capability. Engage all company employees in change management strategies.
- Promote talent strategies to grow quality capabilities, provide development opportunities and drive a global mindset.

**Connect**
- As the Management Representative, engages Management and relevant Leadership Teams in Quality Reviews and Escalations based on appropriate analytics, tools and reports. Identifies and sponsors initiatives for
- improvement of the opportunity areas and proactively navigate legal/regulatory changes that may significantly impact the business.
- Directs QMS activities to ensure continual compliance of the Site Quality Management System in accordance with J&J Enterprise Quality System, MedTech segment requirements and local government regulatory requirements. Oversee the quality processed for distribution and inventory management activities at Distribution Center and Distributor.
- Responsible for escalation and execute immediate actions for risk mitigation.
- Establishes robust processes eg product labelling and product release. Ensures thorough investigation, comprehensive risk assessment and flawless execution of actions in relation to non conformances, deviations, CAPA, change management and Field Actions. Oversees timely product quality complaints and adverse event reporting and resolutions.
- Lead supplier Quality Management program for all GxP suppliers, distribution center, distributors, logistics and transportation suppliers
- In partnership with Supply Chain/Deliver, provide Quality input and oversight on distribution network changes

**Shape**
- In collaboration with business functions/management, develop and implement strategies through integration of early risk evaluation, mitiga