Regulatory Affairs & Compliance Manager, PET Production Facility

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 Pharmacyo* Food and Drug Administrationo* Radiation Safety Departmento* 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

Qualifications

LICENSES, CERTIFICATIONS, and/or REGISTRATIONS: 

Specify minimum credentials and clearly indicate if required or preferred.  

Preferred: Certification in quality management or other cGMP certification.

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

Onsite60 Blossom Street40RegularDay (United States of America)

Pay Range

$97,510.40 - $141,804.00/Annual

Grade

8At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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