BrightOwl Loader Loading

Head of GCD Quality Assurance - EU Vienna Austria,  


Posted on : 20 May 2017

Project Description

  For Vienna, Austria we are looking for a Head of GCD Quality Assurance - EU (m/f) 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 in Vienna, Berlin and Paris facilities.    Essential Functions:  Management: Responsible for QA staff management in accordance with the Celerion'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 Position Location: office based in Vienna, Austria Contract: Full-time Start: As soon as possible  

Locations

Vienna Austria

Find a Job Find Candidates

Most Recent Searches

Most Famous Searches

You might also like