Beschreibung

• • Dec 11, 2023
  • 3 min read

Global QA Patients Operations Manager - Japanese

Updated: Jan 24

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. The Global QA Patients Operations Manager will ensure a consistent approach to the operational oversight of Apheresis Network Onboarding and Maintenance as well as troubleshooting within this scope in support of clinical and commercial operations in the region.

Responsibilities:

• Support development and review of Patient Operations processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage.
• Support Quality Patient Operations liaison(s) to logistics, manufacturing process/personnel and associated apheresis and final drug product troubleshooting; provide real-time quality event support including but not limited to: decision-making for apheresis collection, shipping patient materials, and chain of identity discrepancies.
• Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the product lifecycle.
• Provide Quality review and approval of training materials, internal and external procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation in support of Apheresis Network onboarding and maintenance.
• Provide Global Patient Services (GPS) system general support, data configuration approvals, SOP review and approval.
• Quality Operations and Systems Support including deviation management, change management, complaints, CAPA, compliance guidance.
• Support Key Performance Indicating metrics to ensure continuous improvement.
• Interface with regional clinical specialists and Commercial Launch Excellence Managers.
• Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control.
• Model effective and constructive communication behaviors and interactions with technical departments both orally and in writing.
• Serve on project teams by providing quality assurance guidance and input regarding quality systems application and execution in support of project activities.
• 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 and act in a decisive manner; communicate difficult observations in a calm and cogent manner.
• Interpersonal skills: excellent communicator, coaches and inspires people to achieve team goals, delivers training to achieve and keep state of the art knowledge, establishes a collaborative environment, and manage interfaces well with other units.
• Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.
• Adaptable/flexible and able to deal with change.
• Enterprise mindset and external focus.
• Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
• In-depth knowledge of Global Health Authorities regulations, Quality Systems principles, and applications to the pharmaceutical industry.

Education/Experience/ Licenses/Certifications:

• Minimum of Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas.
• Minimum of 2 years' experience in Quality Assurance or Quality.
• Operations supporting cellular therapy, with experience in regulated environment (cGMP/GCP/GDP).
• Good organizational skills, including ability to follow assignments through to completion.
• Provide advice, guidance, and support to the organization with regard to quality requirements.
• Good skills in leading, influencing, and negotiating.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Good knowledge and understanding of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions, and to work with minimal supervision.
• Excellent verbal and written communication skills.
• Good skills in leading, influencing and negotiating with cross-functional teams.
• Fluent in Japanese, good level of English

Only applicants eligible to work in Switzerland will be considered e.g. Swiss national, current Swiss work permit holder or cross-border EU citizen.

This position has been filled, please contact to be informed of future similar positions

• Vacancies

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. The Global QA Patients Operations Manager will ensure a consistent approach to the operational oversight of Apheresis Network Onboarding and Maintenance as well as troubleshooting within this scope in support of clinical and commercial operations in the region.

Responsibilities:

• Support development and review of Patient Operations processes and procedures in support of Scheduling, Apheresis Onboarding, Distribution and CDP On-Site Storage.
• Support Quality Patient Operations liaison(s) to logistics, manufacturing process/personnel and associated apheresis and final drug product troubleshooting; provide real-time quality event support including but not limited to: decision-making for apheresis collection, shipping patient materials, and chain of identity discrepancies.
• Collaborate with stakeholders to ensure robust handling and chain of identity standards are maintained throughout the product lifecycle.
• Provide Quality review and approval of training materials, internal and external procedures, apheresis accounts (JAMS), risk assessments, and commercial readiness documentation in support of Apheresis Network onboarding and maintenance.
• Provide Global Patient Services (GPS) system general support, data configuration approvals, SOP review and approval.
• Quality Operations and Systems Support including deviation management, change management, complaints, CAPA, compliance guidance.
• Support Key Performance Indicating metrics to ensure continuous improvement.
• Interface with regional clinical specialists and Commercial Launch Excellence Managers.
• Assist with compliance and other regulatory inspections and in developing remediation efforts and responses. Recognize opportunity for improvement, driving CAPA and/or change control.
• Model effective and constructive communication behaviors and interactions with technical departments both orally and in writing.
• Serve on project teams by providing quality assurance guidance and input regarding quality systems application and execution in support of project activities.
• 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 and act in a decisive manner; communicate difficult observations in a calm and cogent manner.
• Interpersonal skills: excellent communicator, coaches and inspires people to achieve team goals, delivers training to achieve and keep state of the art knowledge, establishes a collaborative environment, and manage interfaces well with other units.
• Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.
• Adaptable/flexible and able to deal with change.
• Enterprise mindset and external focus.
• Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
• In-depth knowledge of Global Health Authorities regulations, Quality Systems principles, and applications to the pharmaceutical industry.

Education/Experience/ Licenses/Certifications:

• Minimum of Bachelor's degree in biochemistry, biology, microbiology, chemistry, engineering or closely related areas.
• Minimum of 2 years' experience in Quality Assurance or Quality.
• Operations supporting cellular therapy, with experience in regulated environment (cGMP/GCP/GDP).
• Good organizational skills, including ability to follow assignments through to completion.
• Provide advice, guidance, and support to the organization with regard to quality requirements.
• Good skills in leading, influencing, and negotiating.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Good knowledge and understanding of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions, and to work with minimal supervision.
• Excellent verbal and written communication skills.
• Good skills in leading, influencing and negotiating with cross-functional teams.
• Fluent in Japanese, good level of English

Only applicants eligible to work in Switzerland will be considered e.g. Swiss national, current Swiss work permit holder or cross-border EU citizen.

This position has been filled, please contact to be informed of future similar positions

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