Description

MANPOWER AG – Your career, our focus!
Become part of our network and take advantage of countless opportunities!
ManpowerGroup is the world's leading company for workforce solutions.
With our three brands – Manpower, Experis, and Talent Solutions – we support companies from various industries with their recruitment needs. For 75 years, we have been operating in over 75 countries and accompany our clients throughout Switzerland to successfully carry out their tasks and projects.
Global Quality Manager IMP Distribution / QA Compliance Manager Clinical Supply Chain (m/w/d)
We are looking for an experienced quality professional to join the IMP Quality Distribution team. In this role, you will help ensure the quality and compliance of Investigational Medicinal Products throughout the global clinical supply chain, in line with international GMP and GDP standards.
General Information
Start date:
Latest possible start date:
Duration: 12 months
Extension: very likely
Location: Basel
Workload: 100%
Home Office: 40% possible, 60% on site
Travel: none
Team: 7 people
Department: IMP Quality Distribution
Working hours: standard working hours
Background
IMP Quality Distribution is part of Global Quality Assurance and is responsible for maintaining the quality and compliance of clinical trial materials across the global supply chain. The team provides QA oversight for the global IMP Distribution Network and works closely with key stakeholders in Global Clinical Supply Chain Management Distribution.
This position offers a global scope and plays an important role in safeguarding product quality, regulatory compliance and reliable supply for clinical trials.
Tasks and Responsibilities
Act as Delegate of the Swiss Responsible Person / FvP for quality-related decision-making
Maintain global QA oversight of the IMP Distribution Network and relevant Clinical Supply Chain interfaces
Lead deviation management activities, including product quality impact assessments
Review and assess final evaluations, quality statements and CAPA proposals from third parties
Ensure that proposed CAPAs are appropriate and aligned with regulatory expectations
Manage quality documentation and change records throughout their lifecycle
Establish, review and approve internal procedures and external business documents
Support and drive GxP inspections and audits
Manage temperature excursion assessments for clinical trials
Prepare, review and manage expert statements and quality opinions
Review and approve IMP Supply & Release Flowcharts, transfer requests and expert opinions
Establish and approve Master Quality Agreements and Quality Agreements
Manage complaint processes for clinical trials within the Roche network
Support quality-related and business-driven projects within the IMP Distribution network
Drive continuous improvement activities
Ensure compliance with GMP/GDP, Good Documentation Practices and internal PQS requirements
Requirements
Bachelor’s degree in a relevant scientific or technical field, such as Pharmacy, Chemistry, Biology or Engineering
At least 3 years of experience in Quality Assurance with a strong focus on compliance
Strong knowledge of regulated GxP environments, especially GMP and GDP
Experience with quality processes such as deviations, CAPA, change control, audits or inspections
Fluent English skills, both written and spoken
Independent, structured and quality-oriented working style
Ability to assess complex quality topics and make well-founded decisions
Strong communication skills when working with internal and external stakeholders
Nice to Have
Experience with Veeva Vault QMS
Previous Roche experience
PTQ experience
Experience in supplier management, especially with depots
German language skills are an advantage
Ideal Profile
The ideal candidate is an experienced QA professional with a strong compliance mindset and solid knowledge of GMP/GDP requirements. They are confident in handling quality decisions, deviations, CAPA, documentation and inspection-related topics within an international environment. Experience in clinical supply chain, IMP distribution or supplier/depot management would be a strong advantage. jide48cd65a jit0625a jiy26a