uniQure

Sr. Specialist GCP/GLP QA - Lexington

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Job

Active since 23-05-2018 Job category Quality / Health / Environment ...
Location Lexington Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position:

Develop, implement, maintain, and improve GCP and GLP Quality Management Systems per global regulations in clinical and pre-clinical operations, which include: Clinical, Research & Development, Pharmacovigilance, Medical Affairs, Regulatory Affairs, Laboratories, CMC Operations, and vendors.

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

Manage GCP/GLP 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 and GLP 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.
  • Review GLP and GCP study protocols and reports, clinical study reports, external publications, etc.
  • 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/GLP/PV training
  • Develop metric 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 and GLP Quality
  • Travel ~ 20%, primarily domestic
Qualifications:
  • B.S. (Molecular Biology, Biochemistry, Chemistry). Advanced degree is preferred.
  • A minimum of 6 years of experience biopharma industry in a Clinical Quality GLP or Regulatory role.
Core Competencies:
  • Advanced knowledge of global, especially US and EU GCP and GLP guidelines.
  • Experience in hosting regulatory inspections and interactions, especially FDA and EMA.
  • Proven experience in understanding and implementing pre-clinical, clinical and commercial phase processes to meet GCP and GLP regulations.
  • Confident, independent, self-starter, proactive, and results-oriented with high performance standards.
  • 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

Contact information

Name Jennifer Wagner

Location

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