Quality Systems Specialist — Validation & Compliance

Planet Pharma; Waltham (MA); On-site; USD 55,104 - 68,880; Full time

Job summary

A leading pharmaceutical company seeks a Quality System Specialist to support global Quality Systems and ensure compliance with applicable SOPs. Responsibilities include managing Quality System applications, gathering user requirements, and supporting system validation activities. The ideal candidate holds a Bachelor’s degree in a relevant field and has 3-6 years of experience in commercial/clinical pharma environments. Proficiency in MS Word and Excel is essential, with knowledge of Veeva Vault and similar tools desirable. This full-time role is based in Waltham, MA.

Qualifications

• Minimum of 3-6 years of experience in a high volume commercial/clinical pharma/healthcare facility.
• Understanding and working knowledge of US FDA and European regulatory requirements.
• Knowledge of Regulatory Compliance and ICH Guidelines.

Responsibilities

• Support global Quality Systems ensuring compliance with SOPs.
• Assist in governance of Quality System applications and process harmonization.
• Participate in meetings/workshops for requirements gathering.
• Manage change controls and documentation requirements.
• Support validation activities, including test plans and scripts.

Skills

Quality System processes

MS Word

MS Excel

Education

Bachelor’s degree or higher in a relevant field

Tools

Veeva Vault Quality Docs

TrackWise

ComplianceWire

Job description

A leading pharmaceutical company seeks a Quality System Specialist to support global Quality Systems and ensure compliance with applicable SOPs. Responsibilities include managing Quality System applications, gathering user requirements, and supporting system validation activities. The ideal candidate holds a Bachelor’s degree in a relevant field and has 3-6 years of experience in commercial/clinical pharma environments. Proficiency in MS Word and Excel is essential, with knowledge of Veeva Vault and similar tools desirable. This full-time role is based in Waltham, MA.