Regulatory Affairs & Compliance Manager, PET Production Facility
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Job Location:
Boston, NH - USA
Monthly Salary:
$ 97510 - 141804
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 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:
oMassachusetts Department of Public Health
oMassachusetts Board of Pharmacy
oFood and Drug Administration
oRadiation Safety Department
oHospital 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.
EDUCATION:
Bachelors degree required
* Field of Study/Additional Specialized Training including the following are preferred:
- Regulatory Affairs
- Pharmaceutical Science manufacturing or other related field
EXPERIENCE: Indicate the required and preferred (optional) amount and type of 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
Additional Job Details (if applicable)
Remote Type
Work Location
Scheduled Weekly Hours
Employee Type
Work Shift
Pay Range
$97510.40 - $141804.00/AnnualGrade
8EEO Statement:
Mass General Brigham Competency Framework
At Mass General Brigham our competency framework defines what effective leadership looks like by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance make hiring decisions identify development needs mobilize employees across our system and establish a strong talent pipeline.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Patients at Mass General have access to a vast network of physicians, nearly all of whom are Harvard Medical School faculty and many of whom are leaders within their fields.
