uniQure

Sr. GCP Specialist Clinical QA - Lexington, MA

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Active since 09-10-2018 Job category Quality / Health / Environment ...
Location Lexington, MA Level -
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position:

Develop, implement, maintain, and improve GCP Quality Management Systems per global regulations in quality and clinical operations, including vendor oversight.

Promote collaboration with all functional areas to ensure compliance with applicable global GCP, FDA and EMA regulations and company’s Quality Management Systems.

Manage GCP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable FDA, ICH Guidelines and other government and/or country specific regulations.

A summary of the major responsibilities:
  • Ensure all applicable clinical Quality Assurance responsibilities are followed.
  • Maintain QA systems and SOPs for GCP activities.
  • Ensure compliance of clinical development and laboratory activities to applicable quality and regulatory requirements.
  • Ensure all audits are followed-up and corrective actions are completed, implemented, and verified
  • Plan, track and oversee audits of internal and external contract laboratories, contract research organizations and investigator sites.
  • Conduct investigations of GCP-related issues (i.e., non-compliance, quality events) and develop corrective action plans
  • Work in collaboration with clinical sites, Clinical Operations, Clinical Development and Regulatory Affairs and other stakeholders to ensure compliance with GCPs and to maintain inspection readiness; attend study management team meetings, as assigned
  • Ensure QA review of clinical documents such as protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and study reports.
  • Promote/advance quality awareness throughout the organization; coordinate and provide GCP training
  • Develop metrics reports for CQA management of all issues related to the outcome of the audits
  • Prepare, review, approve and manage all relevant documents related to GCP Quality
  • Perform GCP audits, as assigned.
  • Travel ~ 20%, primarily domestic
Qualifications:
  • B.S. (Health Sciences, Biology, Biochemistry, Chemistry).
  • A minimum of 5 years of experience the medical device or biopharma industry in a Clinical Operations, GCP Quality or Regulatory role.
Core Competencies:
  • Advanced knowledge of global, especially US and EU GCP.
  • Awareness of regulatory inspection processes and interactions, especially FDA and EMA.
  • Proven experience in understanding and implementing clinical vendor oversight activities.
  • Confident, independent, self-starter, proactive, and results-oriented with high performance standards.
  • Strong experience with Phase III/pivotal clinical trials.
  • Strong ability to prioritize and operate with a sense of urgency.
  • Solid organizational, analytical and problem-solving skills
  • Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills.
  • Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
  • Strong operational and business acumen
  • Exhibits highest integrity and committed to ethics and compliance standards
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Assurance, GCP

Contact information

Name Jennifer Wagner

Location

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