Assistant Director, Quality & Regulatory Compliance Position Available In Monroe, New York

Assistant Director, Quality & Regulatory Compliance University of Rochester Center for Health + Technology (UR CHeT) Rochester, NY Job Details Full-time $90,000 – $140,000 a year 19 hours ago Benefits Health insurance Dental insurance Tuition reimbursement Paid time off Vision insurance Employee discount Professional development assistance Flexible schedule Life insurance Retirement plan Qualifications Research ethical considerations University research Regulatory compliance Compliance audits & assessments Master’s degree Quality assurance Bachelor’s degree Clinical trials Regulatory Compliance (system development) Research regulatory compliance Quality audits Senior level Compliance standards auditing Compliance 10 years Full Job Description The Center for Health + Technology (“CHeT”) is an academic research organization within the University of Rochester Medical Center. For more than three decades, CHeT has served as a worldwide leader in the conduct, planning, management, implementation, analysis, and rescue of large multicenter clinical research studies. CHeT is looking for an Assistant Director, Quality & Regulatory Compliance, who is responsible for leading the Quality Assurance team for clinical research conducted at the organization and ensures clinical data quality, regulatory compliance, and integrity of research documentation, while collaborating with internal leaders and Principal Investigators.

PAY RANGE + BENEFITS

Full Time, 40 Hours, 8 AM – 5 PM w/ Occasional Weekends Hybrid role; applicants residing in New York State required

Pay Range:

$90,000 – $140,000

Annually Featured Benefits:

Comprehensive health, dental, and vision plans; retirement; tuition assistance; and more available.

Learn more here:

https://www.rochester.edu/human-resources/benefits/ REQUIRED

QUALIFICATIONS

Bachelor’s degree 10 plus years of experience in quality assurance and regulatory roles within the biopharma or medical technology industries or equivalent combination of education and experience

PREFERRED QUALIFICATIONS

Master’s degree Experience in quality and regulatory compliance with investigational products for biologics and medical devices.

RESPONSIBILITIES

Oversees all quality standards and compliance systems relating to routine daily operations through the development and oversight of the Quality Management System (QMS) while complying with Good Clinical Practices (GCP). Manages vendor qualification and management programs, training and development, and document management to ensure compliance and guarantee the highest standards of quality and safety. Supports project and data management and quality assurance teams during clinical trials by leading the development of Standard Operating Procedures (SOPs) and other controlled documents. Maintains expertise of quality standards as set forth in 21 CFR under the FDA and other regulatory agencies, the EU Clinical Trial Directives, and other global regulations relevant to clinical trial operations. Provides guidance to University of Rochester central offices of high-priority, federally regulated research compliance areas.

APPLY NOW + NEXT STEPS

Once your application is received and it is determined that your background meets the requirements of this role, a team member will be in touch to schedule an initial interview and review the full job description. Learn more about the Center for Health +

Technology:

https://www.urmc.rochester.edu/health-technology.aspx Visit CHeT’s LinkedIn page: https://www.linkedin.com/company/ur-chet Contact for more information regarding this role or with any questions.

Job Type:

Full-time Pay:

$90,000.00 – $140,000.00 per year

Benefits:

Dental insurance Employee discount Flexible schedule Health insurance Life insurance Paid time off Professional development assistance Retirement plan Tuition reimbursement Vision insurance

Schedule:

8 hour shift Monday to Friday Weekends as needed

Work Location:

Hybrid remote in Rochester, NY 14620