Regulatory Affairs & Compliance Manager, PET Production Facility

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:oMassachusetts Department of Public Health oMassachusetts Board of PharmacyoFood and Drug AdministrationoRadiation Safety DepartmentoHospital 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

• 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.

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS : Specify minimum credentials and clearly indicate if required or preferred.

Preferred: Certification in quality management or other cGMP certification.

EDUCATION :

Bachelor's degree required

* Field of Study/Additional Specialized Training including the following are preferred:

• Regulatory Affairs

• Pharmaceutical Science, manufacturing, or other related field

Required :

• 3 - 5 years of direct experience in a pharmaceutical manufacturing field

• 2-3 years supervisory experience

Preferred :

• 5 - 10 years of direct experience in a pharmaceutical manufacturing field

• Professional certification

The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Required

Preferred

Job Industries

• Other