Regional Quality Manager

Switzerland  ‐ Onsite
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Description

Our global pharmaceutical client, based in central Switzerland, is currently undertaking an exciting integration project on a global-scale. They are currently looking for a quality manager to oversee and support the distribution team during this unique transition period, with drug products being transferred to new warehousing and storage units throughout the World.

   

Location:             Central Switzerland. Travel required.

Duration:             6-8 months (possibility of extension)

  

RESPONSIBILITIES



- Ensure appropriate issue escalation occurs, relating to any quality or compliance issues. The associate keeps all key stakeholders informed of potential product release delays and any local compliance or regulator challenges in the concerned area of responsibility.   



- Manage the 3rd Parties distributors (external or internal to the client) of the assigned region/countries, ensuring compliance to regulatory and our client’s requirements.



- Act as the main quality contact partner for 3rd party distributors and liaise between them and client manufacturing sites.



- Write, revise and approve Quality Agreements for 3rd party distributors and provide training, ensuring adherence to Quality Agreements requirements as well as our client’s requirements. Ensure Quality Agreements are managed according to V&D requirements i.e. periodically reviewed.



- Manage, review and approve transportation data and perform on-time disposition of vaccine products. Manage transport-related deviations, whilst ensuring root cause analysis is performed and proper remediation actions are defined and timely implemented.



- In collaboration with the V&D Auditing group, ensure that actions deriving from the observations raised during audits of the Unified Quality Audit Program at 3rd party distributors are defined, implemented and in-use (role of QARP and FURP in AQWA).   Ensure proper escalation of overdue actions.



- Participate in compliance audits of 3rd party distributors, as requested.



- Monitoring of 3rd party distributors: Manage risk assessments and ensure proper remediation plan is in place; ensure KPIs reporting; evaluate KPIs trends and escalate negative trends or issue as appropriate.



- Work with 3rd party Distributors and Global Cold Chain Logistic group to ensure proper cold chain qualification.



- Work cross-functionally ensuring all the relevant stakeholders are educated on our client’s V&D Quality requirements.



- Support and supervise quality initiatives and/or GDP upgrade projects and ensure compliance with our client’s standards.



- Managing the distribution switch activities from our client to another organisation.
Start date
n.a
From
Quanta Consultancy Services
Published at
19.09.2015
Contact person:
Lee Mitchell
Project ID:
988058
Contract type
Freelance
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