Regulatory Affairs & Compliance Manager, PET Production Facility

Site: The General Hospital Corporation reputed company 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 reputed company that high-performing teams drive groundbreaking medical discoveries and invite reputed company applicants to join us and experience what it means to be part of reputed company. 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 reputed company 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 reputed company to investigations, environmental monitoring, production
• Record keeping maintaining compliance with the following regulatory authorities:

o Massachusetts Department of Public Health o Massachusetts Board of Pharmacy o Food and Drug Administration o Radiation Safety Department o 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

• The MGH PET Production Facility produces radiopharmaceuticals for clinical use, reputed company research, and non-reputed company 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 reputed company, 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. 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 reputed company 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

Additional Job Details (if applicable) Remote Type Onsite Work Location 60 reputed company Street Pay Range $99,465.60 - $141,804.00/Annual Grade 8 At reputed company, we reputed company in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining reputed company pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The reputed company pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass reputed company elements contributing to your total compensation package. In addition to competitive reputed company 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 reputed company team will provide an overview of your potential compensation and benefits package. EEO Statement: reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religious creed, national reputed company, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that reputed company individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with reputed company of 1990, applicants who require accommodation in the job application process may contact reputed company Resources at (857)-282-7642. reputed company Competency reputed company At reputed company, our competency reputed company defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The reputed company 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 reputed company. These competencies are used to evaluate performance, reputed company hiring reputed company, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Apply tot his job Apply To this Job