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Head of Quality Assurance
Ho Chi Minh City, Vietnam
Requisition ID: 1700168928W
Head of Quality Assurance, One J&J Vietnam
Overall purpose of the job
One Johnson & Johnson (J&J) is a provider of consumer, pharmaceutical and medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease and improve the quality of life of patients and consumers.
The Business Quality Head of One J&J in the country reports solid line to the One SEA Business Quality Senior Director, dotted line to the One J&J Commercial Head and is a member of the Country Leadership Team. The individual is responsible for building and leading its cross‐sector Quality and Compliance Organization in the Country. The role requires partnership and building of alliances with the in‐country Commercial and Supply Chain teams and external stakeholders to proactively determine risks and compliant solutions to the business growth opportunities in the country.
The position is accountable for executing and managing the daily activities of the Quality and Compliance function in the country, from local new product introduction, product importation, change management, deviations and CAPA reporting, labeling 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 needs to ensure compliance of the local company's Quality Management system to standards as defined by One SEA and the Enterprise One Quality System. It should prepare and enable the local organization to maintain continued compliance, navigating through the changing local government regulatory requirements.
The Business Quality Head will also be responsible for planning and managing local budget of the Quality & Compliance Organization, as per alignment with each Sector's targets.
Essential duties and responsibilities
1. Deliver : Directs QMS activities to ensure continual compliance of the Site Business Quality Management System in accordance with J&J Enterprise One Quality System, associated Sector standard, and local government regulatory requirements
2. Connect: As the Management Representative, engages Management and relevant Leadership Team in Quality Reviews and Escalation based on appropriate analytics, tools and reports. Identifies and sponsors initiatives for improvement of opportunity areas and proactively navigate legal changes that may significantly impact the business
3. Shape: In collaboration with business function/management, develop and implement strategies through integration of early risk evaluation, mitigation and development of compliant solutions to identified growth opportunities. Oversees overall development of local organization in terms of Quality and Compliance objectives
4. Lead: Establishes robust process in product labeling 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
5. Confers with Management in preparation, formulating and maintaining organization budget and resources
Essential knowledge and skills
Requires undergraduate degree in Science of Engineering disciplines; graduate degree/studies in Science, Engineering, Business, or equivalent experience are preferred. This strategic role requires a diverse business 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.
Core competencies required for this role
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, e.g., FDA, TGA, notified bodies, etc., and a history of success and credibility resolving complex quality and regulatory compliance issues with crossfunctional teams.
Vietnam-Ho Chi Minh City-Ho Chi Minh City
Johnson & Johnson (Vietnam) Co, Ltd (7338)