Regulatory Affairs & Compliance Manager, PET Production Facility
About The Position
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The MGH PET Production Facility produces radiopharmaceuticals for clinical use, human research, and non-human research applications. The MGH PET Production facility is an FDA registered PET Radiopharmaceutical manufacturing facility. Applicant will work in a cGMP facility located in the Edwards Research Building Basement. This position is mainly office-based, in-person, although a portion of the duties will require working in the laboratory where radiopharmaceuticals are manufactured. While significant safety measures are in place, there is limited exposure to ionizing radiation and a low probability of exposure to volatile chemicals in the laboratory. Staff will wear dosimeters to measure radiation exposure. Work hours may be variable to ensure that departmental needs are met. Job Summary PRINCIPAL DUTIES AND RESPONSIBILITIES: Duties and responsibilities include the following but is not limited to: Authors and reviews of standard operating procedures, technical reports, and other cGMP documents Educates staff and organizational members and project participants on quality improvement methodologies and tools Provides leadership and hands-on participation in projects to develop quality improvement skills Develops a quality improvement culture with staff and leaders to support organizational development Maintains an updated library of FDA regulations and guidance documents Performs annual product quality review for each radiopharmaceutical OOS investigation coordination Change control management CAPA management and verification of efficacy Vendor complaint handling Assists with IND submissions, annual reports, amendments, etc. Maintain inspectional readiness Tracking and trending data related to investigations, environmental monitoring, production Record keeping maintaining compliance with the following regulatory authorities: o Massachusetts Department of Public Health o Massachusetts Board of Pharmacy o Food and Drug Administration o Radiation Safety Department o Hospital Policies Collaboration with PET Production/Cyclotron staff in the performance of quality investigations Maintaining a positive working relationship with vendors and hospital service providers (e.g. Buildings and Grounds) Documentation of facility repairs Calibrated equipment inventory management Equipment IQ/OQ documentation review Documentation management per institution document control policy Leads improvements to quality management system Serves as liaison between industry partners and facility for collab oration work Oversees personnel training program and documentation
Requirements
- Bachelor’s degree required
- 3 – 5 years of direct experience in a pharmaceutical manufacturing field
- 2-3 years supervisory experience
Nice To Haves
- Certification in quality management or other cGMP certification
- Field of Study/Additional Specialized Training including the following are preferred: Regulatory Affairs Pharmaceutical Science, manufacturing, or other related field
- 5 – 10 years of direct experience in a pharmaceutical manufacturing field
- Professional certification
Responsibilities
- Authors and reviews of standard operating procedures, technical reports, and other cGMP documents
- Educates staff and organizational members and project participants on quality improvement methodologies and tools
- Provides leadership and hands-on participation in projects to develop quality improvement skills
- Develops a quality improvement culture with staff and leaders to support organizational development
- Maintains an updated library of FDA regulations and guidance documents
- Performs annual product quality review for each radiopharmaceutical
- OOS investigation coordination
- Change control management
- CAPA management and verification of efficacy
- Vendor complaint handling
- Assists with IND submissions, annual reports, amendments, etc.
- Maintain inspectional readiness
- Tracking and trending data related to investigations, environmental monitoring, production
- Record keeping maintaining compliance with the following regulatory authorities: o Massachusetts Department of Public Health o Massachusetts Board of Pharmacy o Food and Drug Administration o Radiation Safety Department o Hospital Policies
- Collaboration with PET Production/Cyclotron staff in the performance of quality investigations
- Maintaining a positive working relationship with vendors and hospital service providers (e.g. Buildings and Grounds)
- Documentation of facility repairs
- Calibrated equipment inventory management
- Equipment IQ/OQ documentation review
- Documentation management per institution document control policy
- Leads improvements to quality management system
- Serves as liaison between industry partners and facility for collab oration work
- Oversees personnel training program and documentation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
