Description
On behalf my client, a global leader in the plasma protein biotherapeutics industry with more then 1200 employees in Bern area,Switzerland I am looking for:Regional Quality Coordination Officer
Location: Bern Area, Switzerland
Project Start: 01. July 2016
Duration: 1 year- with possible extension
Industry: Pharma-Biopharma
Position Purpose:
The Regional Quality Coordination Officer (RQO) ECI is the primary quality interface between the business partner/Rep. Offices and Quality in assigned territory (ECI) Africa, Middle East, Balkans, Switzerland, Russia & CIS. Currently about 40 active markets.
The position is responsible for quality management related activities to ensure compliance within the area of responsibility with internal policies/ procedures and local regulations.
Reporting Relationships:
The position reports to Director, Regulatory-, and Quality- & Safety Coordination ECI
There are no positions reporting into this position.
Quality Management
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Coordinate Pharmaceutical Technical Complaint (PTC) handling and temperature deviations in ECI Region -
Preparation and coordination of Quality Agreements & One Time Delivery Agreements (OTDAs) in ECI Region. -
Develop Quality procedural documentation in accordance with company's policies and procedures. -
Responsible for PLATEAU (PLATEAU Administrator) for ECI Region -
Responsible for training of internal/external personnel in Quality relevant matters (e.g. PTC handling, temperature deviations etc.) -
Provide support to quality audits (e.g. Quality audits internal and external distributor audits) -
Responsible for compliance with reporting deadlines for deviations/complaints reporting as laid down in relevant SOPs. -
Support Qualification of distributors -
Coordination of quality deviations in ECI (participation in Quality deviation Meetings and discussions) -
Writing and reviewing quality SOP and working instructions -
Support new established affiliates, branches or rep. offices in quality matters
Strategy
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Ensure strategies are aligned within Commercial Operations and follow priorities as communicated by the supervisor. -
Contribute to strategic company's projects as project manager or team member, as required.
Customer Relations
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Support the selection of qualified Quality staff at the distributor/agent. Ensure appropriate, relevant and timely training of Quality functions on adherence to all applicable company's policies/ procedures and guidelines. -
Ensure and organize that the appropriately reviewed and signed Quality Agreements and Confidential Agreements are in place with each collaboration party (e.g. distributor) -
Facilitate mutual understanding and solution finding of country specific matters versus company global interests. -
Timely communication of upcoming audits and trainings. -
Reporting & Communication -
Weekly oral management reporting of key issues (Jour Fix). -
Consolidated written monthly report on key issues and progress. -
Active participation in team meetings, trainings and workshops.
Position Qualifications and Experience Requiremens
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Minimum Master Degree in life-sciences (pharmacy, chemistry, biochemistry), PhD preferable. -
Fluency to negotiate in English and German -
At least 3 years of professional working experience in Quality Management in a multinational innovative pharmaceutical company -
Knowledge in current European regulatory and GMP legislations and guidelines -
Project management experience -
Understanding of regulatory & quality system -
Customer Focus: establishes and maintains effective relationships with distributors and gains their trust and respect and knowledge / understanding of the challenges in ECI markets. -
Planning and organizing: can orchestrate multiple activities at once to accomplish a goal. -
Problem solving: uses rigorous logic and methods to solve difficult problems with effective solutions -
Negotiation: Strong negotiation and communication skills. -
Fast Learner on new software programs. -
Integrity and Trust: a character of loyalty. -
High communication skills
Extra details:
Please note that only aplicants with valid EU passaport will be taken into serious concideration
About me:
I am a specialised recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectation for immediate consideration.
You can reach me on or at