Sr. Quality Manufacturing Operations Specialist

Job Description

Job Title : Quality Development Specialist – Contract (2 Years)

Location : Boston, MA

Managers Note : Not seeking someone with compliance experience. we need experience with Quality agreements with CMOs / Suppliers.

Job Summary :

We are seeking an experienced Quality Development professional with hands-on experience in small molecule manufacturing to support multiple projects within a fast-paced pharmaceutical environment. The ideal candidate will be a critical thinker , able to lead investigations, manage quality agreements with external partners, and ensure compliance with GMP regulations across drug substance and drug product manufacturing.

Key Responsibilities :

• Lead and support Quality Assurance (QA) activities in a small molecule manufacturing environment.
• Manage and review quality agreements with CMOs, suppliers, and vendors .
• Lead event investigations, root cause analysis (RCA), and CAPA implementation .
• Ensure compliance with GMP regulations across Phase 1-3 drug substance and drug product manufacturing.
• Review, update, and maintain batch records, deviations, and CAPAs .
• Collaborate effectively with cross-functional teams and provide clear written and verbal communication .
• Support multiple projects and teams , ensuring timely completion within defined objectives.
• Utilize Veeva QMS or similar quality management systems for documentation and tracking.

Required Qualifications :

Preferred Qualifications :