Massachusetts General Hospital
Regulatory Affairs & Compliance Manager, PET Production Facility
Massachusetts General Hospital, Boston, Massachusetts, us, 02298
PRINCIPAL DUTIES AND RESPONSIBILITIES
Duties and responsibilities include the following but are 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:
Massachusetts Department of Public Health
Massachusetts Board of Pharmacy
Food and Drug Administration
Radiation Safety Department
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
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS 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
EXPERIENCE 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.
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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:
Massachusetts Department of Public Health
Massachusetts Board of Pharmacy
Food and Drug Administration
Radiation Safety Department
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
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS 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
EXPERIENCE 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.
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