Katalyst CRO ยท 1 month ago
Senior GxP Quality Auditor
Greenville, NC
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is seeking an experienced Senior GxP Auditor to lead regulatory compliance activities and alignment of SOPs across site and global teams in a highly regulated pharmaceutical manufacturing environment. The role involves coordinating between Quality teams, providing regulatory interpretation, and facilitating governance meetings.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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