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Quality

Regulatory Compliance Manager APAC (New Consumer Health Company)

  • Titre Regulatory Compliance Manager APAC (New Consumer Health Company)
  • Fonction Quality
  • Sous-fonction Quality (Generalist)
  • Lieu Singapore; Seoul, South Korea; Shanghai, China; Tokyo-To, Japan
  • Date de mise en ligne
  • Référence 2206070875W
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Description

Johnson & Johnson is currently recruiting a Regulatory Compliance Manager APAC New Consumer Health Company. This position will be based in either China Shanghai Gui Qing Rd, Japan Tokyo J&J Headquarter, or Korea Seoul Yongsan gu. 

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.    

 With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. 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.  

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion.   

Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day.  Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.     

Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.         

It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.   

Role & Responsibilities:

The Compliance Manager is responsible for maintaining sustainable compliance programs that are aligned with Regulatory Compliance processes, as well as corporate requirements.  This role will provide cGMP compliance insight for key operational activities regulated by Local and Global Health Authorities/Boards or Health and other relevant regulatory bodies.  This role will work closely with site quality, compliance, operations, and technical operations leadership to cultivate GMP awareness, issue identification, risk mitigation, inspection readiness, and inspection/audit management. This role will have responsibility for maintaining relationships through interdependent partnering and forming alliances with cross-functional Consumer business partners to drive compliant completion of key goals and objectives.  This position will support the Consumer businesses within the APAC region. 

Qualifications

Position Requirements:

  • A minimum of a Bachelor’s degree is required.  An advanced degree is preferred. A focused degree in science, engineering, or equivalent is strongly preferred 

  • Minimum of eight to ten (8-10) years of experience in a quality and/or compliance environment within the OTC, medical device, diagnostic, and/or cosmetic industry is required 

  • Understanding of requirements for compliant cosmetic, drug, and medical device manufacture including facilities, equipment, documentation, testing, and product flow is required 

  • A solid understanding of quality and compliance in a regulated manufacturing environment (GMP) is required 

  • Experience with or how regulatory bodies approach inspections and how to respond to regulatory body observations is required 

  • Working knowledge of New Drug Regulations and GxP/Quality System Regulations 

  • Strong decision-making, influencing, negotiating, networking, and relationship-building skills 

  • Strong personal leadership with demonstrated competency in collaborating with cross-functional leadership 

  • Experience working in global and multicultural settings 

Preferred Requirements/Competencies:

  • Exercises independent judgment and execution in anticipating, interpreting, evaluating, and resolving complex organization situations while appreciating the direct impact on the operational results of the business 

  • Knowledge of regulatory and development process (both pre-approval and post-launch monitoring) and scale-up 

  • Ability to translate complex information for a wide range of cross-functional leaders 

  • Effective experience with handling resistance to change 

  • Ability to drive solutions and meet goals independently 

  • Exceptional written and verbal communication skills 

  • Experience handling multiple, highly complex projects 

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