Manager, Commercial Quality - 2406161680W

　　Description

　　Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

　　Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo . It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

　　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

　　Engage and lead MedTech initiatives to improve efficiencies and provide subject matter expertise, as a primary Quality partner, to other functions.

　　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, mitigation and development of compliant solutions to identified growth

　　Partner and collaborate with both Enterprise and RA organisations to ensure timely gathering of new/revised requirements while sustaining country specific Business activities.

　　Foster a culture of accountability, ownership, inventiveness and empowerment.

　　Oversee development of A&D strategy to ensure appropriate deployment of quality systems for the new business.

　　Confers with Management in preparation, formulating and maintaining organization budget and resources

　　Qualifications

　　Degree in Science or Engineering disciplines, graduate degree/studies in Science, Engineering, Business, or equivalent experience is preferred.

　　This strategic role requires a diverse quality background, preferably with direct experience in multiple product categories, with specific quality and regulatory compliance competencies in the areas of market quality, quality operations or quality systems.

　　A minimum of 10 years of experience in positions of increasing responsibility. Proven success in business engagement, strategy development, project management and execution, change management, understanding linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority, driving alignment on strategy and approach across multiple differing health authority requirements, building consensus and impacting outcomes.

　　Previous experience interfacing with regulatory agencies and/or notified bodies, etc. and a history of success and credibility resolving complex quality and regulatory compliance issues with cross-functional teams.

　　Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

　　At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

　　Primary Location Asia Pacific-Singapore-Singapore-Singapore

　　Other Locations Asia Pacific-Malaysia-Selangor-Petaling Jaya

　　Organization Johnson & Johnson International (Singapore) Pte Ltd (8438)

　　Job Function Customer/Commercial Quality

　　Req ID: 2406161680W