Job Description

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GCP Inspection Management Framework Rollout and Change Management (remote) / no-835
by GCP Inspection Management Framework rollout and Change Management (remote) / no-835
in CH-Basel
Employment Type
Freelance or CH-Payroll
Workload
100% Part time Porsition
Start
23.06.2025
End
31.10.2025
All - In / Hour
Rate negotiable
Deadline
19.06.20 12:00 am
Total Hours
GCP Inspection Management Framework rollout and Change Management (remote) / no-835
Industry
Company size
Founded in
Phone
Show
Phone
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Email
Location
CH-Basel
Website
For our customer located in Basel/remote, Switzerland we are currently looking for a: GCP Inspection Management Framework Rollout and Change Management [remote] (m/f/d)

• Location: CH-Basel and remote
• Workload: 100 % Part time Position
• Branch: Pharma
• Duration: 23.06.2025 - 31.10.2025
• Contract: Freelancer or CH-Payroll

Tasks & Responsibilities
The CQA team needs PJM and Change Management support to finalize the playbook, drive the playbook rollout within RDQ, and to support and drive change management with the cross-functional teams, with a target date to complete the process in October '25.

• Clinical Quality Assurance (CQA) plays a pivotal role in ensuring that clinical trials are conducted in compliance with regulatory requirements, internal policies, and ethical guidelines.
• A key responsibility of the team includes the centralized governance of non-routine GCP Health Authorities (HA) inspections and the management of the inspection lifecycle.
• To strengthen capabilities in HA GCP inspection management, the CQA team has formalized their approach into a framework.
• CQA is now working on a playbook to summarize the framework, and tools. The Playbook will cover Planning, Knowledge Management, and Lifecycle Management with a specific focus on the inspection. The rollout of the Playbook will require a focused change management approach within CDA / RDQ and across Line Functions. Training of key roles will be required and targeted approaches to support Inspection Preparation teams to move into the defined ways of working.

Must Haves

• Previous experience delivering project successfully in a large, complex and matrix-based pharmaceutical organization
• Previous knowledge of organisation is strongly preferred
• Strong ability to synthesize structure and produce customer focused communications, slide decks and simplify complex information
• Great verbal and written communication skills in English
• Stakeholder management skills
• Good collaborative skills

Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.
Employment Type
Freelance or CH-Payroll
Workload
100% Part time Porsition
Start
23.06.2025
End
31.10.2025
All-In / Hour
Rate negotiable
Total Hours
Deadline
19.06.20 12:00 am
GCP Inspection Management Framework rollout and Change Management (remote) / no-835
Industry
Company size
Founded in
Phone
Phone
Show
Email
Location
CH-Basel
Website
GCP Inspection Management Framework Rollout and Change Management (remote) / no-835
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