Research Regulatory Manager-Department of Neurosurgery-GMP Lab
About The Position
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. Reviews and audits all Facilities, Manufacturing and Quality Control facility and equipment calibration/validation. Reviews and approves all equipment installation/operational qualification protocols and associated reports. Reviews and releases/rejects all raw materials used for Facilities, Manufacturing and Quality Control. Provides Regulatory Support to GMP projects Works with the Director of GMP and Project Sponsors to ensure all GMP projects comply with Federal Regulations. Regularly reviews FDA publications and notifications for relevant information/updates. Works with the Director of GMP 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. Assists with the development, drafting and subsequent revision of all Chemistry, Manufacturing and Controls (CMC) with the Director of GMP and Project Sponsors for all Investigational New Drug (IND) Applications. Facilitates 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 with GMP Regulations. Provides supervision of regulatory staff
Requirements
- Bachelor's degree and four years of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- At least 3 years GMP Manufacturing, Quality Control or Quality Management (or previous regulatory experience).
Responsibilities
- 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.
- Reviews and audits all Facilities, Manufacturing and Quality Control facility and equipment calibration/validation.
- Reviews and approves all equipment installation/operational qualification protocols and associated reports.
- Reviews and releases/rejects all raw materials used for Facilities, Manufacturing and Quality Control.
- Provides Regulatory Support to GMP projects
- Works with the Director of GMP and Project Sponsors to ensure all GMP projects comply with Federal Regulations.
- Regularly reviews FDA publications and notifications for relevant information/updates.
- Works with the Director of GMP 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.
- Assists with the development, drafting and subsequent revision of all Chemistry, Manufacturing and Controls (CMC) with the Director of GMP and Project Sponsors for all Investigational New Drug (IND) Applications.
- Facilitates 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 with GMP Regulations.
- Provides supervision of regulatory staff
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What This Job Offers
Job Type
Full-time
Career Level
Manager
