Senior GxP Quality Auditor

Senior GxP Quality Auditor

Katalyst CRO

2 weeks ago - Be among the first 25 applicants.

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.

• 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, elevate risks, and report status to leadership.
• Review and approve protocol templates, summaries, and reports.

• Bachelor's degree in a related field.
• 7+ years industry experience in GxP environments.
• Strong experience with pharmaceutical bracketing & matrixing strategies.
• Proven compliance background with FDA, EMA, MHRA regulations.
• Experience in pharmaceutical manufacturing / FDA‑regulated environments.
• Strong understanding of cGMP and validation requirements.
• Excellent writing, communication, and cross‑functional collaboration skills.
• Strong analytical, problem‑solving, and critical thinking abilities.
• Must work onsite full‑time in Greenville, NC.

• Mid‑Senior level

• Contract

• Quality Assurance

• Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x.

Apply BELOW