Regulatory Affairs & Compliance Manager, PET Production Facility

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
• 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 collaboration work
• Oversees personnel training program and documentation

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
:
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

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.