Job no: 517257
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Facilities/Skilled Trades, Other, Research/Scientific/Grants
Department:29680247 - MD-CTSI-SVC CGMP GENE THERAPY

Classification Title:

Research Regulatory Manager

Job Description:

The CTSI is actively recruiting for a Research Regulatory Manger. This position is responsible for medical education, medical care, and clinical research activities for the Cellular and Gene Therapy Core. The incumbent is responsible for Quality Management and regulatory functions of assigned Good Manufacturing Practice (GMP) projects.

Provides Quality Management Oversight to GMP projects

• Responsible for coordinating all GMP document control for all operational units in the GMP Group.
• Prepares and issues all working copies of manufacturing production documents and QC testing documents.
• Audits all GMP Facilities, Manufacturing and Quality Control documentation for accuracy and compliance with GMP Regulations.
  Reviews and approves all deviation and investigation reports from Facilities, Manufacturing and Quality Control.
• Reviews and approves all Quality Control Assay Qualification Protocols. Audits and approves all QC qualification reports.
• Review and Audit all Facilitates, Manufacturing and Quality Control facility and equipment calibration/validation. Review and approve all equipment installation/operations qualification protocols.
• Review and audit all equipment installation/operational qualification reports.
• Review and release/reject all raw materials used for Facilities, Manufacturing and Quality Control.
• Manage all controlled document archives for GMP.

Provides Regulatory Support to GMP projects

• Work with Director of Operations and Project Sponsors to insure all GMP projects comply with Federal Regulations. Regularly review FDA publications and notifications for relevant information/updates.
• Work with Director of Operations and Project Sponsors to ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol IND/IDE submissions, annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports. Serves as primary liaison to regulatory bodies.
• Assist with development, drafting and subsequent revision of all Chemistry, Manufacturing and Controls (CMC) with the Director of Operations and Project Sponsors for all Investigational New Drug (IND) Applications.
• Facilitate all sponsor directed or regulatory mandated inspections/audits. This includes hosting and drafting, review and transmittal of any associated reports.

Provides GMP and Regulatory Training for GMP Personnel

• Provides annual GMP regulatory training for all GMP Personnel.
• Maintains standards for GMP manufacturing and quality control operational conduct and integrity and ensures compliance within GMP Regulations.

Provides supervision for regulatory staff.

Expected Salary:

$72,000 to $90,000; commensurate with education and experience.

Minimum Requirements:

Bachelor’s degree and four years of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:

At least 3 years of Good Manufacturing Practice (GMP) experience, quality control or quality management, and/or previous regulatory experience.

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

This is a time-limited position.

This requisition has been reposted. Previous applicants are still under consideration and need not apply.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required:No

Advertised: 23 Jul 2021 Eastern Daylight Time
Applications close: 30 Jul 2021 Eastern Daylight Time