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Job Details

Global Regulatory Affairs Quality Operations Manager (f/m)

Company: Optimus Search Limited
Location: Marburg-Biedenkopf
Reference: BBBH7576
Closing Date: 30 Aug 17
Type: Permanent
Salary (£): 80,000 - 100,000
Benefits:

Job Summary:

Global Regulatory Affairs Quality Operations Manager (f/m)Salary: €90,000 Annually Location: Germany - Marburg or Bern Main Responsibilities and Accountabilities: * Procedural documents/Quality Management System * Responsible for the GRA QMS, including implementation of QMS strategy and tactics * Responsible for supporting and coordinating GRA internal Policy/SOP/WI creation, review, approval, version control and ensuring consistency across * Regular review of global procedural documents sta ...

Requirements:

Global Regulatory Affairs Quality Operations Manager (f/m)

Salary: €90,000 Annually

Location: Germany - Marburg or Bern

Main Responsibilities and Accountabilities:

* Procedural documents/Quality Management System
* Responsible for the GRA QMS, including implementation of QMS strategy and tactics
* Responsible for supporting and coordinating GRA internal Policy/SOP/WI creation, review, approval, version control and ensuring consistency across
* Regular review of global procedural documents status and analysis of status reports
* Ensure continuous compliance with QMS procedural documents
* Represent GRA in global projects associated with QMS



Training

* Ensure adherence to GRA training strategy
* Implement and maintain training curricula for all GRA functions
* Maintain a GRA training database
* Oversee training status across GRA, collect and analyse regular reports and provide consolidated status report



Audits/Inspections

* Act as a key contact for internal audits of GRA (e.g. by Companies internal audit groups / third party auditors), including coordination of CAPA responses
* Support regulatory agency inspections including pre-inspection and related follow-up activities
* Coordinate and conduct audits of GRA global processes in order to assess and/or ensure compliance with relevant guidelines, legal requirements and GxP guidelines
* Ensure compliance of GRA local procedures with GRA global procedural documents
* Contribute to audit and inspection readiness activities
* Track audits & inspections performed in GRA
* Oversee and track quality incompliances in GRA



Qualifications & Experience:

* A degree (BSc/MSc or equivalent in life science, pharmacy, law or business economics preferred)
* A minimum of 6+ years’ experience in managing Quality Management Systems including procedural document development, Training requirements and conducting audits
* Demonstrated sound judgment and flexible approach to managing situations
* Customer service focus
* Fluent English and German speaker preferred

Apply for this job: Global Regulatory Affairs Quality Operations Manager (f/m)

Contact Information:

Address:  Head Office
171-177 Great Portland Street, London
W1W 5PG
England
Tel:  +44 (0) 20 3418 8033
Fax:  +44 (0) 20 7287 4908
Website:  Visit Our Web Site

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