Associate Director of Quality Assurance of Cmed Research

Geographical Location Horsham, West Sussex, UK
Contact Information ghughes@cmedresearch.com, +44 (0)1403 755423
Applications Before 30 September 2007
Remuneration Competitive
Reference 2007-01-11h

Principal Duties and Responsibilities

The Head of Quality Assurance is responsible for the promotion of a quality driven culture within Cmed by:

Developing and delivering a Quality Assurance Strategy in line with the objectives of the Board of Directors
Managing an appropriate Quality Management System
Verifying that Cmed operations meets the relevant internal standards, good practices and regulatory requirements with regard to policy, procedures and systems
Acting as a consultant on all company quality issues

Principal Accountabilities:

• Establish, implement a global Quality Management System.
• Promote a pragmatic, proactive and supportive culture within the company environment, which maintains an appropriate level of regulatory compliance whilst facilitating the achievement of project deliverables & timelines
• Lead the definition & documentation of appropriate standards of quality. Facilitate implementation by coaching, mentoring & leading personnel
• Identify process gaps and/or quality deficiencies in Cmed global activities, proposing opportunities for improvement & raising awareness of unmet Cmed educational needs.
• Lead Sponsor Company Audits and Regulatory Authority Inspections.
• Pro-actively contribute to global management team discussions by providing quality/compliance management & consultancy on international projects & overall business operations.
• Communicate & clarify audit requirements & process quality control steps by preparing an audit strategy & maintaining an audit and/or quality review plan
• Verify that documented working practices reflect global regulatory requirements. Facilitate the introduction of appropriate streamlined procedures, which remove areas of non-added value activity, aid communication & facilitate the overall development process
• Undertake facility, system and project reviews and report any observed issues to Cmed Senior Management.
• Ensure that a system for collating, monitoring, reporting and closing corrective and preventive action items is established and maintained.
  

Candidate Profile

• B.S. or B.A. in science or healthcare related field with 4+ years in clinical auditing.
• Good working knowledge of the clinical research process, good clinical practice and relevant regulatory requirements.
• Excellent interpersonal, organizational and leadership skills and ability to interact with personnel at all levels.
• Good communicator with ability to work on own or as part of a multi-national team.
• Experience of FDA& EMEA Regulatory Inspections and activities.
• Experience of working within a CRO is desirable.

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