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Job Details

Manager, QA Compliance

Company: Chiltern
Location: United Kingdom,England - Bedfordshire,England - Berkshire,England - Buckinghamshire,England - Hampshire,England - Hertfordshire,England - London,England - Oxfordshire,England - Surrey,England - Wi ...
Reference: JT-899914
Closing Date: 23 Jul 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Chiltern are looking to recruit a Manager, QA Compliance to be based at our offices in Slough, Berkshire. This position provides management support to the Global QA Department, with duties primarily focused on quality system and compliance related tasks and responsibilities.

Requirements:

Job Background

Successful candidates will have the opportunity to be part of a growing company with a strong brand and professional employees that care about the work they are involved in. Chiltern is constantly working to develop training capacity, therapeutic expertise, new technologies and processes to be one of the leading CROs globally.

We can offer competitive salaries, benefits that are designed around you, a strong support mechanism and dedicated coaching to develop your career.

Duties & Responsibilities

  • Responsible for the hiring, performance appraisal, performance management, training, and career development of a team of QA staff.
  • Actively seek feedback, and monitor the quality of their team member’s work on an ongoing basis, through review of appropriate documentation, as deemed appropriate to the team member’s position.
  • Manage the resource aspects of their assigned team, contribute to operational reports, through contribution to the staff allocation process as required
  • Responsible for management, hosting and follow-up of Client audits and regulatory inspection support
  • Ensuring that Chiltern Client audit findings are adequately documented and all responses are provided within the given due-date in the Chiltern eQMS system
  • Activities related to elements of the quality system (per assigned responsibilities) including but not limited to management of quality improvement initiatives / projects; quality data trend compilation, analysis, trending and reporting; and QA departmental training compliance and representation.
  • Provide metrics to Senior Management on quality issues relevant to areas of responsibility.
  • Serves as a role model, mentor and/or supervisor (when needed) for less experienced QA staff.
  • Ensure that systems and processes agreed by management and implemented will ensure that Clinical Trials have been performed and data is generated in compliance with ICH-GCP and other regulations.
  • Actively participates in training sessions and workshops, including presenting reports from any conferences attended.

Requirements
  • 5+ years’ of experience, or an equivalent combination of education and experience
  • Good understanding of clinical research.
  • Proven experience of good interpersonal and communication skills when dealing with Sponsors, supporting colleagues and making presentations
  • Methodical and meticulous, with excellent attention to detail
  • Ability to review procedures in detail and the ability to see the greater overall perspective
  • Ability to work independently and autonomously, with minimal supervision
  • Ability to guide, manage and motivate less experienced staff
  • Ability to train junior members of the QA Compliance team on relevant QA systems, processes and procedures

Additional Information:                           

  • This is a full time permanent position, office based in Slough (UK).
  • For a confidential discussion about this opportunity, please phone 01753 216725. To apply, please send your CV to julia.thomson@chiltern.com - julia.thomson@chiltern.com
  • For more information about Chiltern International, please visit our web site at www.chiltern.com

Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.

Specialties

  • Clinical Trials, Biopharma, Clinical Analytics, Medical Device and Diagnostics, Source (FSP/Resourcing), Oncology, Respiratory, Anti-infectives/Vaccines, Dermatology, Data Management, eClinical, Biostatistics, SAS Programming, and Clinical Monitoring 

Please note that if your experience does not mirror that of our requirements for this role you may not receive a response

 

Keywords

Slough, Reading, Berkshire, QA, Compliance, Manager

Salary

Competitive

Position Type

Permanent
Full Time

Contact

Email Julia Thomson - Julia.Thomson@chiltern.com
+44 (0) 1753 216 725

Apply for this job: Manager, QA Compliance

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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