Manager, Quality [South Korea]

 

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued and rewarded for your performance. Join our Sales team with an unmatched depth of capabilities and help our customers solve some of the world’s toughest challenges.

Manager, Quality

• Location: Youngjong Area (영종도 아레나스 물류센터)
• Type: Regular (정규직)
• Coverage: South Korea
• Pipeline: biological and chemical drugs for clinical trials

To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services approved procedures and policies, cGMP, cGDP, and regulatory requirements.

Maintain the FCS(Fisher Clinical Services) Korea Quality System in compliance with Fisher Clinical Services approved procedure and policies, cGMP, cGDP, and regulatory requirements.

Liaise with clients, internal and external customers on quality related matters.

Essential Duties and Responsibility:

• Ensure the required compliance to relevant internal standards, local and international quality and regulatory guidelines applicable to Good Manufacturing Practice for clinical trials supply chain activities and drive vital improvements.
• Deliver monthly reporting on key performance indicators and provide insights, regarding trends, risks and mitigation plans.
• Provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters.
• Handle internal and external audits, and follow-up on resulting observations and opportunities for improvement.
• Mentor and develop the Quality team to deliver outstanding results.
• Partner and collaborate to find opportunities and solutions related to regulatory and quality matters impacting the business.
• Responsible for management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.
• Ensure that a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
• Leadership role in service and quality improvement initiatives in line with other functional units.

Requirements

• Over 5 years of QA experience.
• Cold Chain experience is highly preferred.
• GMP, GLP, GCP experience is preferred.
• Bachelor’s degree in life science or related medical/Pharmacy/Quality Assurance & Regulatory affair is preferred.
• GMP/QMS settings in the field of quality assurance and regulatory affairs is preferred.
• Business Level or above skills in Spoken English

Ability/Skills:

• Knowledge of IMP process, preferably to include handling complex protocols, key clients and business objectives
• Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
• Flexible and adaptable with strong customer management skills.
• Ability to work independently under pressure and handle multiple tasks
• Ability to lead and influence, and to support others within team
• Good organizational skills
• Good written and verbal communication skills in Korean and English

기타사항

• 지원 시 성함은 여권상의 영문성함과 동일하게 기재하십시오.
• 고유식별정보(주민등록번호, 여권번호 등) 민감정보(종교, 정치 등)는 기재하지 마세요.
• 보훈, 장애 대상자는 관련 서류 제출 시 관계법에 따라 우대합니다.
• 입사지원서 내용에 허위 사실이 판명될 경우, 입사가 취소될 수 있습니다.

For more Thermo Fisher Scientific Korea

• YouTube
• Learn more about us here
• Official Recruiting Blog (Korean)

• Our 4i Values:

Integrity – Innovation – Intensity – Involvement

• Our Mission:

Our Mission is to enable our customers to make the world healthier, cleaner and safer.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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