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Job Details

Quality Assurance Manager

Company: CROMSOURCE
Location: United States
Reference: HQ00001277
Closing Date: 15 Nov 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Title: US Quality Assurance Manager: Waltham, MA (with flexibility to work from home)Schedule: Full time, 40 hours/week     CROMSOURCE is looking for a US Quality Assurance Manager to join our Compliance department. The US QA Manager will act as a liaison in the Compliance Department and with other relevant stakeholders to ensure that CROMSOURCE processes and services delivered in North America are in compliance with Company procedures, ISO 9001, ISO EN 14155, ICH-GCP...

Requirements:

Title: US Quality Assurance Manager
Location: Waltham, MA (with flexibility to work from home)
Schedule: Full time, 40 hours/week

CROMSOURCE is looking for a US Quality Assurance Manager to join our Compliance department. The US QA Manager will act as a liaison in the Compliance Department and with other relevant stakeholders to ensure that CROMSOURCE processes and services delivered in North America are in compliance with Company procedures, ISO 9001, ISO EN 14155, ICH-GCP guidelines, FDA 21 CFR part 11, 312, 803, 812, other GXP applicable regulations or requirements.

The job responsibilities are included but not limited to what is listed below:

  • Collaborates in writing, reviewing, implementing and updating SOPs in order to provide standard work documents for CROMSOURCE to comply with ISO 9001, ISO EN 14155, ICH-GCP guidelines, FDA 21 CFR part 11, 312, 803, 812, other GXP applicable regulations or requirements
  • Prepares, conducts and reports internal and external GXP audits of clinical research activities guaranteeing high quality of these activities
  • Liaises with the project teams and manages the quality aspects of the clinical projects, while safeguarding the independency of the Compliance Department
  • Provides internal training and consulting of GXP subjects and procedures to keep staff knowledge about procedures up to high standards
  • Provides advice and interpretation of FDA regulations and guidelines (Quality Assurance (QA) Helpdesk), answering questions from CROMSOURCE staff regarding Quality System, SOPs, audits and GXP
  • Performs QA consulting activities: auditing, SOP consulting, ISO 9001, GCP and ISO EN 14155 training, FDA 21 CFR part 11, 312, 803, 812 ensuring compliance with procedures
  • Manages follow-up on and evaluates effectiveness of corrective/preventive actions (CAPAs)
  • Conducts properly the delegated activities relevant for the Compliance Department (CDT)

Job requirements:

  • University Degree in scientific, medical or paramedical disciplines
  • A minimum of 5 years' experience in clinical research field
  • Experienced (education, work/audit experience, training) in auditing according to applicable regulations
  • Experience working on an international scale is preferred
  • Strong knowledge of ISO 9001, ISO EN 14155, ICH-GCP guidelines, FDA 21 CFR part 11, 312, 803, 812, other GXP applicable regulations or requirements
  • Advanced English knowledge
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

If you would like to be considered for this exciting opportunity pleased send your CV directly to vicki.wilson@cromsource.com

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

Quality Assurance Manager QA Quality Assurance Compliance GxP Medical Devices United States USA US Waltham Massachusetts

Quality Assurance, Quality Assurance Manager, Quality Assurance Officer, Quality Assurance Specialist

Apply for this job: Quality Assurance Manager

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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