Regulatory Affairs & Compliance Lead — Radiopharmaceuticals

Mass General Brigham; Boston (MA); On-site; USD 99,000 - 142,000; Full time

Job summary

Mass General Brigham seeks a Quality Assurance professional for the PET Production Facility located at 60 Blossom Street. The role focuses on leading QA activities in a cGMP radiopharmaceutical setting, ensuring regulatory compliance and effective documentation practices.

The position requires a Bachelor's in a related field, 3–5 years in pharma manufacturing, and 2–3 years of supervisory experience. Certification and strong quality management skills are preferred.

Qualifications

• Bachelor's degree in a regulatory/pharmaceutical field is required.
• 3–5 years of direct experience in a pharmaceutical manufacturing field is required.
• 2–3 years supervisory experience is preferred.
• Professional certification is preferred.

Responsibilities

• Authors and reviews SOPs, technical reports, and CGMP documents.
• Educates staff on quality improvement methodologies and tools.
• Provides leadership in projects to develop quality improvement skills.
• Maintains FDA regulations and guidance documents library.
• Performs annual product quality review for radiopharmaceuticals.
• Oversees CAPA management and verification of efficacy.
• Coordinates OOS investigations and change control processes.

Skills

Quality management

cGMP knowledge

Regulatory affairs

Process improvement

Documentation control

Leadership

Education

Bachelor's degree in Regulatory Affairs/Pharmaceutical Science or related field

Professional certification

Job description

Mass General Brigham seeks a Quality Assurance professional for the PET Production Facility located at 60 Blossom Street. The role focuses on leading QA activities in a cGMP radiopharmaceutical setting, ensuring regulatory compliance and effective documentation practices.

The position requires a Bachelor's in a related field, 3–5 years in pharma manufacturing, and 2–3 years of supervisory experience. Certification and strong quality management skills are preferred.