Regulatory Affairs & Compliance Manager, PET Production Facility

Principal Duties and 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
• 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
• Aids 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 collaboration work
• Oversees personnel training program and documentation

Qualifications

• Bachelor’s degree required
• Field of Study/Additional Specialized Training including the following are preferred:
• Regulatory Affairs
• Pharmaceutical Science, manufacturing, or other related field
• 3 – 5 years of direct experience in a pharmaceutical manufacturing field
• 2-3 years supervisory experience

Additional Job Details (if Applicable)

• Remote Type: Onsite
• Work Location: 60 Blossom Street
• Pay Range: $99,465.60 - $141,804.00/Annual
• Grade: 8

Professional Certification

• Preferred: Certification in quality management or other cGMP certification

EEO Statement

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.

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.