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Senior QA Auditor Europe (GCP)

MMS is a growing clinical research organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. Our strong industry experience and scientific approach to drug development makes us a valuable partner in creating compelling submissions that meet rigorous regulatory standards. Our clients span from top 10 pharma to virtual biotechs, and we support each one with the same standard of excellence. Our core service areas include medical and regulatory writing, biostatistics, clinical programming, data management, clinical development, clinical trial disclosure, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patient’s lives worldwide.

This role is a newly-created position that will have responsibility for leading GCP audits in Europe. This is a home based position. Candidates can be located anywhere in Europe.

Responsibilities:

  • Plan, prepare and conduct investigator site, process, quality system, computer system, vendor qualification audits and other types of clinical trial and pharmaceutical-related audits as required.  Report findings to the auditees and/or client.
  • Assist with the development of a corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.
  • Assist with quality assurance training for internal and client staff as needed.
  • Write audit plans, reports and other required audit documentation. 
  • Coordinate internal and external reviews and finalize documents according to project timeline.
  • Perform internal quality assurance (QA) audits (including document and process audits) per procedure as needed.
  • Assist with SOP, work practice, and other quality documentation development and review.

Required Qualifications:

  • Bachelor’s degree or higher in biomedical, nursing or related life science discipline required.
  • Minimum 2 years of related experience or relevant pharmaceutical and/or CRO experience in a Quality Assurance department preferred.
  • Comprehensive understanding of GxP/ICH Guidelines and relevant regulations.
  • Excellent, demonstrated verbal and written communication skills
  • Ability to travel up to 50% both domestically and internationally.
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