Vice President, Corporate Quality
INC Research - Raleigh, NC

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Job Summary

Responsible for the development, resourcing and direction of the Corporate Quality Department. May include oversight of legal compliance.

Core Responsibilities

1.Direction for and oversight of a comprehensive, global internal Quality Assurance program that contributes to the goals and outcomes of the Company’s quality management system and processes, including the conduct of independent audits to assess compliance of processes and projects; a vendor qualification program; management of reported quality issues; and management of sponsor audits and resulting feedback.

2.Production and maintenance of an annual Audit Schedule that assures assessments of an adequate sample of the on-going projects and functional areas to enable management to make reliable determinations on the status of compliance across the Company’s operations.

3.Quality issues management, tracking and trending.

4.Quality and compliance advising and counseling.

5.Training operational staff in relevant regulatory requirements.

6.Managing and hosting Sponsor audits and inspections by regulatory authorities.

7.Independent oversight of the Company’s computer system development life cycle processes and implementation to ensure compliance with relevant regulatory requirements and industry expectations.

8. Development and maintenance of a system for the controlled production and distribution of Company Standard Operating Procedures (SOPs) and related controlled documents.

9.Liaise within Legal Division to assess, develop and respond to Quality Issues and corporate compliance matters.

Other Responsibilities:
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Skills & Attributes

J.D. preferred but not required, plus 15 years extensive experience in Quality Assurance/management roles with increasing levels of responsibilities in a clinical research and development environment, or an equivalent combination of educational and professional experience. Prior experience in a Contract Research Organization is a plus, and prior in-house experience is also a plus. Requires extensive and comprehensive knowledge of regulations and guidelines pertaining to Good Clinical Practice, including FDA regulations and EU Directives, ICH Guidance and related requirements and expectations pertaining to clinical research activities. Legal compliance (FCPA, U.K. Bribery Act, etc.) experience is preferred, but not required. Extensive prior experience in staff supervision and management is required. Ability to handle multiple tasks in a dynamic environment, and to effectively communicate with and motivate staff at all levels of the organization is essential. Requires effective organizational, presentation, documentation, facilitation and interpersonal skills.

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

INC Research is an EEO, M/F/D/V and a drug-free workplace. INC Research voluntarily participates in the federal E-Verify work authorization program.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to jobs@incresearch.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

INC Research is a company headquartered in the United States and that the personal information collected on its websites may be sent to, stored or processed in the United States or to any other country in which INC Research or its affiliates, subsidiaries or agents maintain facilities. While INC Research is committed to providing your voluntarily disclosed employment application information with a reasonable level of privacy protection, you should know that the general level of protection for personal information in the United States may not be the same as that provided in other countries. By using the INC Research website and/or providing INC Research with personal identifiable information, you fully understand and unambiguously consent to the transfer and the collection and processing of such information in the United States.

INC Research - 2 years ago - save job
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INC Research is not fazed by the four phases a new drug has to go through to get from idea stage to commericial adoption. The contract...