Lead CSV Engineer for Digital Quality

Alkermes; Massachusetts; Hybrid; USD 110,000 - 126,000; Full time

Benefits offered by this job

Hybrid work model

Office in Waltham

Job summary

Alkermes in Massachusetts is seeking a Senior Digital Quality lead to provide leadership and accountability for CSV across the organization’s QA, Regulatory, and R&D systems.

You will drive validation activities, risk assessments, and documentation throughout the system lifecycle, ensuring GxP compliance, an inspection-ready posture, and alignment with regulatory expectations.

The role offers a hybrid work arrangement with onsite presence in Waltham and collaboration with cross-functional teams.

Qualifications

• Bachelor's degree required with 9+ years in Digital Quality in a GxP pharma/biotech environment.
• Experience with quality systems, data integrity, and compliance.
• Knowledge of 21 CFR Part 11, ICH Q7/Q8/Q9/Q10.
• Excellent communication and leadership skills.
• Experience leading cross-functional teams.

Responsibilities

• Lead CSV activities across Quality, Regulatory, and R&D systems.
• Represent CSV in project teams and report progress.
• Conduct risk assessments per Quality Risk Management policy.
• Develop, review, and execute validation documentation across the lifecycle.
• Support inspections and audits with CSV-related responses and actions.

Skills

Digital Quality

GxP compliance

Regulatory knowledge

Leadership

Cross-functional collaboration

Data integrity

Validation activities

AI validation exposure

Education

Bachelor’s degree in computer science, Life Sciences, Engineering, or related field

Master’s degree (7+ years experience considered)

Tools

LMS

Veeva DMS

TrackWise

TrackWise Digital

ValGenesis

Job description

Alkermes in Massachusetts is seeking a Senior Digital Quality lead to provide leadership and accountability for CSV across the organization’s QA, Regulatory, and R&D systems.

You will drive validation activities, risk assessments, and documentation throughout the system lifecycle, ensuring GxP compliance, an inspection-ready posture, and alignment with regulatory expectations.

The role offers a hybrid work arrangement with onsite presence in Waltham and collaboration with cross-functional teams.