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Sr. / Manager, GCP/GLP/GVP Quality Assurance

Cambridge, MA

Posted: 11/03/2020 Employment Type: Direct Hire Job Category: Clinical: Quality Job Number: 2683

Job Description

This role is an exciting opportunity to be a part of the Quality Assurance organization. We are looking for a dedicated resource that can contribute to our client' s transition from an early clinical phase Biotechnology company to a company that will support late phase clinical trials.

Reporting to the Sr. Director of R&D Quality and located at the client’ s headquarters in Cambridge, MA, this individual will (i) be a key contributor to and be responsible for helping to establish and sustain the Quality Management System for the areas of GCP, GLP and GVP; (ii) be a key contributor and support the systems of clinical Corrective Actions/Preventive Actions (CAPAs) and Clinical Issues, and other quality systems for ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). The appointee will also be responsible to partner with clinical study teams and other Clinical Development functions, as necessary, to create a quality culture and help reach a sustained state of inspection readiness.

Responsibilities Include:
  • Assist in improving the client' s overall Quality Management System (QMS), including policies and procedures while keeping them current with emerging and changing regulations.
  • Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic systems.
  • Manage the performance and effectiveness of the quality system programs such as change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.
  • Manage the issuance of audit reports and the tracking/monitoring of corrective responses to audit findings to completion.
  • Participate in internal audit program and third party/regulatory inspection programs for the Cambridge facility.

Requirements / Qualifications:
  • BS/BA, with at least 8 years’ of Quality Assurance experience in Biotech, Pharma or Clinical Research Organization.
  • Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and/or GLP regulations.
  • Experience working with CROs, vendors, and relationship management preferred.
  • Experience managing essential documentation (GCP/GLP/GVP: Policies, SOPs, JDs, Training Records, CVs, etc.) working to good documentation practices.
  • Familiarity with common Safety databases (e.g. ArisG, Argus) preferred.
  • Excellent clinical/non-clinical judgment and ability to communicate complex clinical/non-clinical issues in a scientifically sound and understandable way.
  • Excellent communication skills (verbal and written).
  • Ability to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Meet Your Recruiter

Aaron Goldman
Principal Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past nine years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!

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