Director - Quality Assurance - Cardiovascular Research Foundation - New York

Job description

Director, Quality Assurance
This position is responsible for overseeing the Quality Assurance and Regulatory function for the pre-clinical research facility and the Clinical Trials Center. Direct reports include Quality Assurance Manager, GCP and Quality Assurance Manager, GLP. Carries out supervisory responsibilities in accordance with CRF’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving issues.

Job Functions:
Implements and maintains CRF’s quality program; promotes and facilitates continuous quality improvement.
Translates regulations, requirements, and guidelines into CRF policy.
Identifies and resolves internal CRF quality issues, (e.g. identifies and helps resolve problems and/or issues with processes across departments.)
Ensures compliance with Good Clinical Practice (GCP) and acts as expert GCP/GLP consultant to groups within CRF.

Conducts project specific, system, and vendor audits.
Conducts internal quality assurance audits of clinical trial data and records, including clinical databases, monitoring files and study files. Reviews clinical documents for compliance to stated CRF SOPs, formats and regulatory requirements (protocols, amendments, sample case report forms, Informed Consent forms).
Writes and/or reviews all CRF’s SOPs to insure appropriate codification of GCP/GLP procedures.
Conducts training on SOPs, regulatory requirements and quality initiatives.
Develop/maintain CRF’s SOP and quality policy training program and files.
Serves as CRF’s primary contact to client/sponsor companies for regulatory and quality assurance issues.
Leads preparation for client/sponsor audits and regulatory inspections.
Manages client/sponsor audits and regulatory inspections; leads tours, presents requested documents and answers questions.
Develop processes with CTC personnel to ensure compliance with quality processes and procedures.
Oversees SCCR quality programs, ensuring compliance with Good Laboratory Practice (GLP) requirements. Reviews Study Plans and pre-clinical SOPs.

Benefits:
Choice of health plans include medical, dental and vision coverage. Company-paid short-term and long-term disability and life insurance. Health and dependent care flexible spending accounts. Pre-tax travel expenses through TransitChek program. 401(k) plan. Generous paid time off (PTO). Ten paid holidays each year.

Desired Skills and Experience
BS/BA in scientific discipline or equivalent experience required.
8 - 10 years regulatory experience and at least 4 years of management experience required. GCP auditing and compliance experience in a pharmaceutical or clinical research organization and federal regulatory experience in the medical device industry strongly preferred.
Extensive knowledge of GCP, GLP, ICH guidelines, FDA guidelines, and other applicable regulatory requirements.
Must be proficient in Microsoft Excel, Word, and Outlook.
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment. Must be able to prioritize.
Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.
Ability to analyze information and solve problems relating to quality assurance and regulatory issues

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