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Head of GCD Quality Assurance - EU - Austria  

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Posted on : 20 May 2017

Project Description

Description:
The Head of GCD Quality Assurance - EU will provide day-to-day guidance, supervision and support for the quality assurance functions for Line of Service (LOS) Global Clinical Development Europe (GCD - EU) and QA staff/functions.



Essential Functions: 

 Management:  
  • Responsible for QA staff management in accordance with the company's policies and applicable laws. 
  • Responsibilities include interviewing and training GCD auditors; planning, assigning, performing and directing work; approval of local QA auditing documents, appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees. 



Quality Management System:
  
  • Primary contact for support to GCD operations for the implementation of QMS LOS (GCD) procedures. 
  • Ensure local QA SOPs are in line with Global QA SOPs 
  • Coordinate and facilitate LOS (GCD) Quality Council Meetings 
  • Drive quality process improvement initiatives. 
  • Change management advocate for staff 
  • Oversee metrics analysis 
  • Oversee quality issues resolution 



Client/Sponsor Audits and Regulatory Authority Inspections: 
  • Oversee and facilitate the preparation, execution and follow-up of client/sponsor audits and regulatory authority inspections. 
  • Coordinate all activities during client/sponsor audits and/or regulatory authority inspections. 
  • Track observations/findings from client/sponsor audits and regulatory authority inspections. 
  • Coordinate the action items/QIs/CAPAs and responses for client/sponsor audits and regulatory authority inspections. 



Vendor, System-based and Study Audits (internal audits and external audits): 
  • Oversee and perform vendor (external supplier) qualification/cyclic audits, issue the audit findings in a written report to management/vendor, and follow-up on findings to closure. 
  • Oversee, perform and follow-up on internal systems-based audits, issue the audit findings in a written report to management/LOS, and follow-up on findings to closure. 
  • Oversee, perform and follow-up on study-specific audits, issue the audit findings in a written report to management/study team, and follow-up on findings to closure. 



Manage day-to-day Quality Assurance Activities: 
  • Primary contact for auditing of study reports, site/study documents, and study data to assure compliance with protocols, procedures, and applicable regulatory requirements and guidelines. 
  • Ensure audit reports to assure the results accurately reflect the study data and documents generated during the study. 
  • Assure management that audits of study phases, audits of site study data and final reports, and audits on internal facilities are in compliance with company policies, procedures, and regulatory guidelines. 
  • Oversee and perform live event audits of studies in progress, as applicable. 
  • Interact with internal clients to discuss QA observations and study related issues. 
  • Provide guidance on administrative duties and responsibilities. 
  • Lead and participate in the review and/or the writing of SOPs, as required. 
  • Coordinate and/or facilitate local regulatory training as required. 
  • Provide guidance for and perform internal and external audits. 
  • Oversee and compile audit findings in a written report format for each study phase audited and maintain QA files and records accordingly. 
  • Participate, monitor and evaluate follow-up on quality issues, corrective and preventive actions. 
  • Interface with clients/sponsors and other departments to ensure needs and deadlines are being met. 
  • Quality check study conduct issues, deviations, investigations, and change control documentation, as required. 
  • May lead the performance initiatives intended to improve quality within the LOS (GCD). 
  • Provide LOS (GCD) internal/external consulting on QMS and GxP aspects 
  • Participate in Global QA budget preparation and administration. 
  • Perform other functions as assigned by Global QA management 



Manage Global Clinical Development (GCD) Auditing Programs:
  
  • Co-development and review of GCD Audit Programs, identifying systems/processes, vendors, studies and Investigators to be audited. 
  • Oversee, conduct and assist with the performance of GCD Audits (Internal Systems/Processes, study files and Investigational sites). 
  • Assist in vendor management, through conducting QA Audits of current and potential vendors. 



Knowledge/Skills/Education/Licenses: 
  
  • Bachelor’s degree in science or similar 
  • Minimum of 5 - 7+ yrs. of GCP Phases IIb, III, & IV QA experience (no GLP or GMP only candidates will be considered) 
  • Minimum of 10+ yrs. pharmaceutical/device clinical research industry experience 
  • Minimum of 2+ yrs. Supervisory/management experience 
  • Proficient knowledge of GCP/cGLP/cGMP, ICH Guidelines E2A, E6, & E8, European Directives on GCP, US FDA CFR - Title 21 Regulations and guidelines, as well as local regulatory authority regulations 
  • Regulatory Authority Inspection experience 
  • System/Process, Vendor and Study Audit experience 
  • Quality Management System (SOPs) experience 
  • Ability to work independently and in a team environment 
  • Excellent time, resource, project and budget management skills 
  • Excellent oral and written communication skills 
  • Ability to work with minimal supervision 
  • Excellent organization, prioritization and problem-solving skills 
  • Ability to occasionally work outside of standard business hours 
  • Computer proficiency in MS Office (other software a plus) 
  • Ability to travel internationally 
  • Fluency in English