Katalyst CRO · 8 hours ago
Senior Supplier Quality Engineer
Warsaw, IN
Contract
Onsite
Senior LevelKatalyst CRO is seeking an experienced Senior Supplier Quality Engineer to lead supplier quality assurance activities for external manufacturing partners within a pharmaceutical/regulated environment. The role involves managing supplier quality assurance, approval, and qualification, while collaborating cross-functionally to ensure compliance and mitigate risks.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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.
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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