Job Description:
Seeking an experienced Senior GxP Auditor to lead regulatory compliance activities, alignment of SOPs, and bracketing strategy across site and global teams in a highly regulated pharmaceutical manufacturing environment.

Responsibilities:

Lead coordination between site and global Quality teams on SOP alignment and bracketing strategy.

Provide regulatory & technical interpretation to ensure compliance with FDA, EMA, and MHRA.

Develop and defend bracketing justification for traditional lines, RABS, and isolators.

Facilitate governance meetings, escalate risks, and report status to leadership.

Review/approve protocol templates, summaries, and reports.

Requirements:

Bachelor's degree in a related field.

+ years industry experience in GxP environments.

Strong experience with pharmaceutical bracketing & matrixing strategies.