Johnson & Johnson Careers
[Janssen Vaccines] Head of QA
Requisition ID: 1805677513W
"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
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 and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
Janssen Vaccines is in Bio Industry Complex of Incheon Free Economic Zone (SongDo International City), Korea where can see the beautiful sunset of West Sea. Janssen Vaccines belongs to the group of Johnson & Johnson pharmaceutical companies operating under the “Janssen Pharmaceutical Companies of Johnson & Johnson” trademark and manufactures high quality pharmaceutical products and innovative vaccines products. Janssen Vaccines has a stellar history of supplying innovative vaccines to the global markets. Today, it is growing as a strategic sterile manufacturing site in ASPAC where has impressive pipeline of new and innovative products for U.S market and global.
For our site in Incheon, we are looking for a committed Head of QA.
Position: Head of QA
Sector: Janssen Vaccines (얀센백신)
Location: Songdo, Incheon
Responsible for QA oversight of clinical and commercial parenteral manufacturing at the Janssen Vaccines Incheon site. This includes quality oversight of all relevant activities in API, sterile fill and finish, and packaging/labeling of drug product manufacturing process.
1) Responsible for the oversight of all quality activities associated with the clinical and commercial manufacturing of parenteral dosage forms at the Incheon site. This will include establishment/ maintenance of QA programs, procedures, and controls, batch assessment and release, deviation and CAPA management, inspection readiness, product quality performance management, trend reporting, and compliance to Quality Management Systems.
2) Provides active quality and compliance support and leadership to the site operational and quality units.
3) Qualified person registered in MFDS Korea. Spokesperson in health authority inspections.
4) Drives a culture of proactive quality and continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.
5) Manages team performance and succession planning through training and development
6) Maintains a culture of high employee engagement, collaboration, flexibility and competitiveness by increasing business and scientific acumen, industry knowledge and executional skills
7) Deputy for Site Quality Head
1) Bachelor’s degree in Life Sciences, Pharmacy or Engineering. Licensed pharmacist preferred.
2) Minimum 5 years in a leadership role within a global supply chain in Quality Operations or Manufacturing in pharmaceutical or biotechnology industry.
3) Strong understanding of parenteral manufacturing and knowledge of global regulatory requirements
4) Experienced in leading health authority inspections
5) Demonstrated leadership and people development skills in either Quality or Manufacturing Operations
6) Ability to operate in a global matrix organization with multiple stakeholders.
7) Strong decision making and problem-solving competencies
8) Excellent communication skills in Korean. Fluency in verbal and written English.
9) Flexible, motivated and innovative team player.
10) Strong foundation in risk management tools and experience in deployment of proactive risk mitigation tools.
11) Ability to influence and negotiate across the organization at all levels.
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