346138BR
Jun 02, 2022
Japan

Job Description

Job Purpose:
Based on Novartis Quality Manual and Policies, the following are achieved under local
regulations.
• Management of all quality related operations and activities in Sandoz Japan
• Quality responsible for Sandoz Japan products as Statutory Quality Assurance
Supervisor
• Keep regulatory compliance under GxP/QMS and related local regulations
• Stable supply to high quality products
• Satisfy customers from quality point of view

Major Accountabilities:
1. Ensure adequate reporting of adverse events / technical complaint / compliance issue
in accordance with company procedures
2. 100% timely delivery of all training requirements including compliance
3. Efficient communication with relevant departments in timely manner
4. Quality Management System
 Implement and maintain the local Quality System in GxP areas, in
accordance with the Novartis Quality Manual, the NCQ-J Quality Plan, and
the local regulatory requirements through:
 Implementation of global quality documents in the Japan Country
 Contribution to the NCQ-J Quality Plan preparation, implementation
and follow-up
 Contribution to the Quality Risk Assessments
5. Ensure QMS is mantained for document management, training management and ecompliance
in the Japan Country
6. Manage the following regulatory compliance activity under GQP/QMS Work together
with other line functions to keep the compliance of Japan approval files for the
products
 Entering into quality agreement with manufacturing sites and maintain it
 Change control related to product quality
 Oversight GMP manufacturing sites from GQP point of view
 Support projects of new launched product and product transfer
7. Quality information handling, e.g.,
 Proper collection of quality information and share with relevant department
 Proper and efficient handling of quality information
 Rapid and proper management of critical quality information
 Publish response letter for customer
 Visit customers for apology and technical explanation
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 Periodical reporting of complaint KPIs
 Proper cooperation with Supply Chain, Patient safety, NTO quality, etc.
 Proper operations of complaint reporting systems
 Provide training on product quality complaints to Japan Country members
 Proceed market actions, including product recall
8. Deviation handling in NCQ Japan
 Status monitoring and trend analysis
 Report to Quality Assurance Supervisor
 Review CAPA justification and effectiveness checks
9. Ensure that a timely and effective communication and escalation process is communicated to and followed by all personnel in their respective area
10. Quality improvement
 Proceed continuous quality improvement in corroboration with relevant business units
 Reduce product quality complaint by improvement of product quality
11. Manage Quality Agreement between manufacturers, both internal and external sites, and co-marketer
12. Fulfill the responsibility of the Document Management Responsible Person, Education & Training Responsible Person, and Market Release Responsible Person
13. Support projects of new product launch and product transfer
14. Provide guidance for the preparation, conduct and follow-up of GMP related audits at the Country Japan
15. Ensure the preparation, facilitate the conduct and coordinate the follow-up of GMP and Pharmacovigilance related local and foreign Health Autority inspections at the Country Japan

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
 
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
 
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
 
Imagine what you could do here at Sandoz!
 
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education:
Bachelor of Science or equivalent
Experience/Professional requirement:
1. Knowledge of the PMDAct and related regulations
 cGMP / GQP / GCTP / GDP / QMS
 ICH guidelines
 Novartis Quality Manua / Quality Directive
2. Knowledge of quality for pharmaceuticals, medical devices and human cell therapy / gene therapy products
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3. Knowledge of Sandoz products
4. Knowledge of HSE regulations and Novartis HSE requirements
5. Person who has engaged in the quality assurance duties or other similar duties for at least three (3) years, or person who can engage quality assurance duties properly and efficiently, approved by Quality Assurance Supervisor
6. Complete all necessary training for QA IT system operations
7. Complete the Investigator Certification Program defined by Novartis Training business unit
English Skill:
Business Level (writing, speaking)
Novartis Technical Operations
NTO QUALITY
Japan
Tokyo
Quality
Full Time
Regular
No
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346138BR

Head, Commercial Operations QA Division

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