Job Description

Overview:

Lead and perform Clinical Quality Assurance (QA) initiatives and duties at PharPoint Research, including all project and non-project activities performed. Responsible for assisting with the creation and implementation of 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).

What you will do:

• Provide consultation and assist with decisions as it relates to the company and departmental QA strategy and departmental goals.
• Generate, approve and implement external and internal audit plans and processes.
• Organize and conduct internal audits in accordance with the internal audit schedule.
• Coordinate and host sponsor audits; manage and implement responses to audit observations.
• Plan, schedule, conduct and report investigator site audits, Trial Master File (TMF) audits and vendor audits.
• Coordinate and assist in regulatory inspections; assist with coordinating and implementing responses to inspection observations.
• Develop and maintain ongoing key QA compliance metrics observed from quality processes, audits and Quality Events.
• Provide Quality Assurance support, guidance and management of Quality Events, Corrective and Preventive Action (CAPA) Plans and deviations.
• Provide ongoing QA support and guidance to Operations.
• Serve as the QA Lead and primary QA contact for assigned projects/clients. Attend and participate in sponsor and internal project-specific meetings periodically.
• Generate, review and revise SOPs and QA documents.
• Complete and review QA-related components on RFIs, proposals and bids.
• Act as line manager for QA staff and oversee the development of junior-level QA staff.
• Provide training to junior-level QA staff.
• Provide support and adhere to all aspects of PharPoint’s QMS.
• Review and ensure compliance with PharPoint’s data integrity and business ethics requirements.
• 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, management, or related discipline. Advanced degree or clinical/technical certification(s) preferred.
• Experience: Minimum 8 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.

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

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