Senior Quality Assurance Manager

TFS Princeton , NJ 08540

Posted 1 week ago

The Senior Quality Assurance Manager is a senior position in the Quality Assurance & Training Department.

The Senior Quality Assurance Manager is capable of independently conducting work related to the development, improvement and daily management TFS QMS as well as conducting all types of GxP audits including system audits according to TFS policies, SOPs and regulatory requirements.

The Senior Quality Assurance Manager n has a broad experience in clinical research and quality assurance and is able to provide support and advice throughout this area.

Essential job functions:

  • Assist and independently contribute to the development and improvement of TFS Quality Management System
  • Provide quality assurance advice and support to internal and external clients
  • Prepare, conduct and follow up on all types of internal and external GxP audits including System, Investigator site, Document, Pharmacovigilance, Data Management
  • Assist in preparing investigational sites for regulatory inspections
  • Facilitate customer audits of the company and/or projects
  • Review audit reports for other quality assurance personnel
  • Provide quality assurance advice and support to internal and external clients
  • Act as quality assurance lead auditor when applicable
  • Train other quality assurance personnel as required
  • Participate in internal meetings as required and liaise with other departments as necessary
  • Develop new (and review existing) quality assurance SOPs as required
  • Maintain required knowledge of applicable regulations and company GxP standards and procedures
  • Assist in writing SOPs for other departments
  • Assist in providing input into proposals, which include quality assurance
  • Assist with business development of external quality assurance services
  • Accompany Commercial Operations colleagues on customer visits and participate in presentations when required.
  • Act as trainer at TFS Academy

Requirements

  • University/college degree or equivalent industry experience
  • Awareness of global trends, government policies and regulations in the clinical trials area
  • In depth knowledge of GxP regulations and guidance
  • Good computer skills (Microsoft Word and Excel)
  • Ability to work independently and efficiently
  • Good planning, organization and problem solving abilities
  • Fluent in English, both written and verbal
  • Several years experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.)
  • Five to 10 years experience of auditing in two to three GxP areas
  • International travel to audit sites, worldwide
  • Membership of a quality association (e.g. the Research Quality Association)

Benefits

Benefit package to be discussed during interview process

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Senior Quality Assurance Manager

TFS