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Katalyst CRO · 9 hours ago

Senior Supplier Quality Engineer

Warsaw, IN

Contract

Onsite

Senior Level

Katalyst Healthcares & Life Sciences is seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical and regulated environment. The role involves managing supplier quality assurance, approval, and qualification, while driving supplier development and mitigating quality risks.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead supplier quality assurance for externally manufactured pharma products

Own supplier approval & qualification, including audits and quality system assessments

Drive supplier development to improve process capability, compliance, and inspection readiness

Manage supplier change control (process changes, transfers, equivalency, obsolescence)

Plan and execute supplier process validations aligned with GMP & ISO standards

Identify and mitigate supplier quality and supply risks proactively

Collaborate cross-functionally with Sourcing, R&D, Manufacturing, Quality, and suppliers

Qualification

Supplier Quality EngineeringGMP knowledgeISO standardsAudits experienceChange managementStakeholder engagementCommunication skillsProject management

Required

Strong Supplier Quality Engineering experience in pharma or regulated industries

Solid knowledge of GMP, ISO, and regulatory expectations

Hands-on experience with audits, validation, and change management

Excellent communication, project management, and stakeholder engagement skills

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.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

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 Stage

Leadership Team

John Patil

Recruiter, Pharma/CRO Staffing Division

Recent News

Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal

2024-04-07

Company data provided by crunchbase