Head of GCD Quality Assurance - EU - Austria
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.
- 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.
- 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