Senior GMP Documentation Lead

Bachem; Vista (CA); In loco; USD 82.000 - 113.000; Tempo pieno

Descrizione del lavoro

Bachem Americas in Vista, CA seeks a Technical Writer III to lead complex GMP documentation for manufacturing, validation, tech transfer, and lifecycle management. You will ensure regulatory alignment and standardization across major programs and site initiatives.

You will mentor junior writers, drive documentation best practices, and coordinate cross-functional teams to deliver compliant, scalable documentation across digital and traditional systems.

Competenze

• Advanced understanding of GMP documentation requirements and lifecycle management.
• Experience leading complex GMP documentation programs across functions.
• Ability to mentor less experienced writers and promote documentation best practices.

Mansioni

• Lead authoring, revision, review, implementation, and lifecycle management of GMP documentation.
• Maintain technical documentation for process validation, risk management, CPV, and technology transfer.
• Coordinate reviews, set timelines, and drive completion of documentation deliverables.
• Support digital documentation initiatives, electronic batch records, and workflow improvements.
• Mentor junior Technical Writer I and II personnel and support knowledge management.

Conoscenze

GMP documentation

Cross-functional leadership

Mentor writers

Documentation lifecycle

Regulatory alignment

Formazione

Bachelor's Degree

Master's Degree

PhD

Strumenti

MasterControl

Descrizione del lavoro

Bachem Americas in Vista, CA seeks a Technical Writer III to lead complex GMP documentation for manufacturing, validation, tech transfer, and lifecycle management. You will ensure regulatory alignment and standardization across major programs and site initiatives.

You will mentor junior writers, drive documentation best practices, and coordinate cross-functional teams to deliver compliant, scalable documentation across digital and traditional systems.