Principal Study Quality & Compliance Scientist

Novartis Group Companies; Cambridge (MA); Hybrid; USD 119,700 - 234,000; Full time

Job summary

Novartis Group of Companies in Cambridge, MA, seeks a Principal Scientist I/II to oversee Study Quality and Compliance within Preclinical Safety. You will ensure GLP‑compliant records, train personnel, and support inspections and archiving.

Experience with SEND datasets and regulatory submissions is desirable. The role blends scientific leadership with operational rigor, requiring 8+ years in pharmaceutical toxicology and strong planning/communication skills.

Qualifications

• Degree in biological related sciences.
• 8+ years of relevant pharmaceutical experience.
• Experience in GLP settings and regulatory compliance.
• Animal welfare knowledge related to toxicology studies.
• Excellent communication and planning skills.
• Fluent in English (spoken and written).

Responsibilities

• Oversee periodic review and maintenance of PCS SOPs with stakeholder input.
• Ensure training records, CVs, and JDs comply with GLP requirements.
• Support Archives Record Management (ARM) and coordinate transfers to permanent archiving locations.
• Support SEND package creation and quality review for FDA submissions.
• Track and manage study-related information across multiple workstreams.

Job description

Novartis Group of Companies in Cambridge, MA, seeks a Principal Scientist I/II to oversee Study Quality and Compliance within Preclinical Safety. You will ensure GLP‑compliant records, train personnel, and support inspections and archiving.

Experience with SEND datasets and regulatory submissions is desirable. The role blends scientific leadership with operational rigor, requiring 8+ years in pharmaceutical toxicology and strong planning/communication skills.