Company: INC Research
Location: UK Regional
Closing Date: 13 Feb 17
Salary (£): Negotiable
Directs the development, resourcing and business development of the global Quality and Compliance Consulting Services Team.
1. Manages the development and implementation of contracted Quality Assurance (QA) Services ensuring compliance with applicable regulatory requirements and guidelines and Company policies and procedures for the delivery of services, including;
• Review and approval of all Requests for Proposals (RFPs) pertaining to contracted QA Services;
• Attracting and developing new business for this group;
• Meeting revenue targets for this business unit;
• Reviewing monthly backlog with Finance;
• Management of (staff) resources and schedules to ensure services are completed in accordance with contractual commitments and Sponsor requirements.
2. Performs line management responsibilities for QA staff. Approves courses of action on interviewing and selection, terminations, professional development (including specific QA training), performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and methods. Manages and provides training and support to QA Auditing staff, and oversees compliance with Company and Department requirements, policies and procedures.
3. Provides periodic summaries of audit findings, results and metrics on the status of the contracted QA Services, as well as the overall status of compliance with regulatory requirements, Company procedures and practices, and project specific requirements (as identified through the audit program) to Senior QA and Operational Management, and proposes strategies for improvement to quality and compliance of Operations and services based on that status.
4. Provides regulatory compliance input and advise to internal project team members as needed, and serves as a Subject Matter Expert on FDA requirements pertaining to clinical research and related regulations, including proposing strategies for the implementation of new or revised regulatory requirements and working with the Training Department to develop training for implementation as needed.
5. Assists with the development and review of QA procedures, audit plans, checklists and other tools.
B.A./B.S. degree in a scientific discipline or health care field or equivalent in education and experience plus extensive experience in Quality Assurance in a clinical research environment such as a Contract Research Organization (CRO) or Pharmaceutical/Biotechnology company; and moderate supervisory/management experience. In some cases, a combination of past performance and prior related experience may be considered provided that the individual demonstrates the outlined knowledge, skills and abilities to perform the job duties. Comprehensive knowledge of FDA regulations, ICH Guidelines and related requirements pertaining to clinical research. Ability to handle multiple tasks in a dynamic environment is essential. Effective organizational, presentation, documentation, interpersonal, and attention to detail skills.
INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
|Tel:||+36 1 489 48 56|
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