Head of QC (Quality Control) - based/Darmstadt - Freelance

Darmstadt, Germany

Reference	LP-2020
Contract type	Contract

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.
Here at inVentiv Health Clinical at the moment we are looking to appoint an experienced "Head of QC (Quality Control)". Responsible for design, develop, implement, maintain, monitor and improve a harmonized and cost effective Quality Management System (QMS) for Global R&D and GxP operations within the CH Holding. This person will be seconded to our client in Darmstadt-Germany, with a 7 months Freelance contract (possible extension if positive performance & need), on a Full time basis 100%. Start date June 2013.



Main Responsibilities:

* Quality supervision on GxP and product quality related operations incl. internal audit program establishing and coordination incl. evaluation.
* Provision of Global R&D documentation management and training system on an overview and systematic level.
* Define the quality strategy of CH in collaboration with EC and deploy it CH-wide incl. provision of implementation support on a local level; deployment to be done by global quality standards and procedure to be implemented on a local level.
* Monthly, quarterly and annual reporting about quality indicators for Global R&D; Quarterly KPI monitoring of local KPIs reported to Head of Quality CH on a quarterly basis.
* Monitor and assess the level of compliance with Functional and Group Quality Policies and Standards across CH.
* Provide guidance and assistance to CH departments and local quality management for improvement.
* Responsible to ensure full involvement of local quality management during the process (development, implementation and maintenance) of quality systems and interface partners regarding their roles and responsibilities.
* Supervise, guide, motivate and develop related staff as well as managers to support, supervise and develop their employees.
* Performing and evaluating Full site audits acc. GMP requirements to assess the level of compliance of suppliers, contractors or internal organizations.
* Realize Authorized person role within the process of Product Quality Alerts and conveys the decision in a decisive and self-confident way in the communication and representation towards senior management.
* Support and provide Quality aspects in clinical trial management and for the Investigational products supply including Vendor selection and Qualification measures and for Quality Contracts.
* Identify and support top talent in order to build strong teams, and foster a culture that retains and maximizes the potential of team members.



Profile:

* Bachelor's Degree required (Life Sciences, Pharmacy or Medicines).
* Minimum 8 years experience in clinical development and the pharmaceutical indus­try preferably with at least 6 years in Quality Control roles.
* Capable of working independently as well as part of a cross-functional team demonstrat­ing the ability to influence and create align­ment across multiple functional areas.
* Fluent in English and German (oral and written).



To apply for this position you must hold a Passport from the EU or a valid visa to work there, and be willing to work office-based 100% for our client under a Freelance contract.

Please apply via E-mail:



Contact:
Lara Pianca, BSc
Recruiter
Obere Wiltisgasse 52, Küsnacht, 8700 SWITZERLAND
P: +41 (0) 44 918 75 24

Expires on

6/14/13 2:01 PM

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