Strategic IT Compliance & CSV Lead — Associate Director

Bristol Myers Squibb; Harvard (MA); On-site; USD 177,000 - 214,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and financial protection

Paid time off

Job summary

Bristol Myers Squibb is hiring an Assoc Director of BI&T Compliance & CSV at Devens, MA. The role oversees IT compliance, CSV processes, and validation across GMP operations, collaborating with Digital Plant and cross-functional teams.

We seek a senior leader with extensive experience in regulated IT, FDA and GxP standards, and strong project leadership to drive continuous improvement and regulatory readiness across the site.

Qualifications

• Bachelor's degree in Engineering, IT, CS or related field.
• 12+ years in pharmaceutical quality operations, QA, QMS, CSV or IT compliance.

Responsibilities

• Lead the Campus IT Compliance and CSV team.
• Provide CSV process guidance to Digital Plant and site groups.
• Define and track SLAs for IT compliance activities.
• Collaborate with site leaders to reduce support volumes and improve processes.
• Represent site in internal audits and regulatory inspections.

Skills

Leadership

Regulated IT

CSV

GxP compliance

FDA collaboration

Documentation

Problem solving

Cross-functional

Regulatory knowledge

Education

Bachelor's degree in Engineering/IT/CS

Tools

ServiceNow

Job description

Bristol Myers Squibb is hiring an Assoc Director of BI&T Compliance & CSV at Devens, MA. The role oversees IT compliance, CSV processes, and validation across GMP operations, collaborating with Digital Plant and cross-functional teams.

We seek a senior leader with extensive experience in regulated IT, FDA and GxP standards, and strong project leadership to drive continuous improvement and regulatory readiness across the site.