Global QA Patients Operations Manager - Japanese
Jo
3 min read
Updated: Aug 19, 2024
The Company
* Our client is a global biopharmaceutical company located near Neuchatel, Switzerland.
* Focused on R&D and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and CVD.
* Possibility for part home office working.
The Role
The primary responsibility of the Global QA Patients Operations Manager is to act as regional Quality Single Point of Contact. This role ensures a consistent approach to operational oversight of Apheresis Network Onboarding and Maintenance, troubleshooting within this scope to support clinical and commercial operations in the region.
Responsibilities
1. Support development and review of Patient Operations processes and procedures related to Scheduling, Apheresis Onboarding, Distribution, and CDP On-Site Storage.
2. Support Quality Patient Operations liaison(s) in logistics, manufacturing processes, and troubleshooting of apheresis and final drug products; provide real-time support for quality events, including decision-making for apheresis collection, shipping patient materials, and resolving chain of identity discrepancies.
3. Collaborate with stakeholders to maintain robust handling and chain of identity standards throughout the product lifecycle.
4. Provide quality review and approval of training materials, procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation for Apheresis Network onboarding and maintenance.
5. Support GPS system operations, data configuration approvals, SOP review, and approval.
6. Assist with deviation management, change management, complaints, CAPA, and compliance guidance.
7. Monitor Key Performance Indicators to ensure continuous improvement.
8. Interface with regional clinical specialists and Commercial Launch Excellence Managers.
9. Assist with regulatory inspections and develop remediation efforts and responses, identifying opportunities for improvement and driving CAPA and change control.
10. Model effective communication behaviors with technical departments, both orally and in writing.
11. Serve on project teams providing quality assurance guidance and support project activities related to quality systems.
12. Provide quality representation and direction to Patient Operations and technical teams.
You
Our Client Is Looking For Someone Who Has The
* Ability to think clearly, act decisively, and communicate observations calmly and effectively.
* Excellent interpersonal skills: communication, coaching, inspiring team goals, delivering training, establishing collaboration, and managing interfaces.
* Ability to work independently or with teams in a complex, changing environment.
* Flexibility and adaptability to change.
* Enterprise mindset and external focus.
* Negotiation, risk management, relationship management, and conflict resolution skills.
* In-depth knowledge of global health authority regulations, quality systems principles, and pharmaceutical industry applications.
Education/Experience/ Licenses/Certifications
* Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, or related fields.
* At least 2 years of experience in Quality Assurance or Quality in regulated environments (cGMP/GCP/GDP).
* Experience supporting cellular therapy operations.
* Strong organizational skills and ability to follow through on assignments.
* Advisory skills regarding quality requirements.
* Leadership, influence, and negotiation skills.
* Innovative, proactive, resourceful, committed to quality and continuous improvement.
* Knowledge of relevant regulations and guidance, able to serve as a resource.
* Decision-making capability, conceptual thinking, minimal supervision.
* Excellent communication skills in Japanese and English.
Additional Notes
Only applicants eligible to work in Switzerland (Swiss national, current Swiss work permit holder, or cross-border EU citizen) will be considered.
This position has been filled; please contact recruitment@consultantsinscience.com for future opportunities.
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