Director, Quality Assurance

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Description
BASIC SUMMARY:
Oversees Quality Assurance (QA) department at PharPoint Research, including all project and non-project activities performed. Responsible for overseeing all quality initiatives at the company, including but not limited to, Standard Operating Procedures (SOPs) and training, computer systems validation (CSV), and Quality Management System (QMS).
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES: Provide direction as it relates to QA strategy and departmental oversight. Provide oversight on SOPs and training. Review training files, SOPs, and Quality Action Plans. Review, revise, and submit revisions of SOPs and all QA documents. Perform training on QA related SOPs. Provide ongoing QA support and work review as needed. Oversee and manage periodic internal audits and assist in new client support. Adhere to all aspects of PharPoint's QMS. Comply with PharPoint's data integrity and business ethics requirements. Interact and review QA-related components on proposals and bids. Perform other related duties incidental to the work described herein. Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition. Perform all other related duties as assigned. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
QUALIFICATIONS: Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific, computer, or related discipline. Advanced degree or technical certification(s) preferred. Experience: Minimum 10 years of experience in clinical trials or related field. Minimum 6 years in quality assurance, quality control, and/or validation. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Certification/Licensure: None. Other: Expert knowledge and understanding of ICH E6 (R2) Good Clinical Practice Guidance, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality. Knowledge expert in industry regulations and standards. Demonstrated professional presentation capabilities. Ability to read, write, speak and understand English required. PHYSICAL DEMANDS: While performing the duties of this job, the employee is regularly required to talk, hear, and type/work at a computer. Specific vision abilities required by this job include close vision and the ability to adjust focus. WORK ENVIRONMENT: General office working conditions, the noise level in the work environment is usually quiet. This position requires occasional domestic/international travel. Must have a valid driver's license with no limitations on driving availability.
Employer Statement
We're in the business of helping clients improve global health. We're proud to offer more than just a stable paycheck - we foster an environment of understanding, and value a better work-life balance. Here, your voice matters. Our teammates are innovative, industry-leading professionals and experts in their fields. Together, we do big things. Join us today as we work together towards a healthier tomorrow.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
PharPoint is unable to sponsor work visas at this time.
Full-Time/Part-Time Full-Time
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
This position is currently accepting applications.
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Location:
Durham, NC, United States
Job Type:
PartTime
Category:
Management Occupations

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