Director, GMP QA Operations — Biotech Quality Leader

Dyne Tx; Waltham (MA); On-site; USD 188,000 - 230,000; Full time

Job summary

A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will have over 10 years of experience in GMP Quality Operations and leadership experience in a biotech environment. This role will ensure compliance with quality standards and foster cross-functional collaboration to support continuous improvement initiatives. Competitive salary offered, ranging from $188,000 to $230,000 USD.

Qualifications

• 10+ years of experience in GMP Quality Operations in biotech.
• Experience managing cross-functional teams.
• Ability to interface with a Qualified Person (QP).

Responsibilities

• Manage external quality operations for GMP manufacturing activities.
• Review batch records and analytical method reports.
• Drive continuous improvement and inspection readiness.

Skills

GMP Quality Operations

Leadership

Written and oral communication

Organizational skills

Collaboration

Education

BA/BS degree

Job description

A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will have over 10 years of experience in GMP Quality Operations and leadership experience in a biotech environment. This role will ensure compliance with quality standards and foster cross-functional collaboration to support continuous improvement initiatives. Competitive salary offered, ranging from $188,000 to $230,000 USD.