Quality & Compliance Lead
Core
Primary driver for implementing, maintaining, and continuously improving Regional Quality & Compliance Programs across assigned sites in FDA-regulated manufacturing environments.
Role type
Senior Quality & Compliance Lead (Life Sciences)
Builds
Quality Management Systems, Audit Readiness status, and superior service levels for pharmaceutical/biotechnology/medical device clients.
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality program development, Non-Conformance Investigations, CAPA management, Vendor Qualifications, Audit support, ISO 9001:2015 compliance, cGMP knowledge, FDA regulations expertise, MS Office proficiency
Preferred skills
EIT or PE certification, Quality Management Software (TrackWise, Success Factors, Infinity, Veeva), Change control processes, Regulatory inspection readiness, Non-compliance trend analysis
Responsibilities
Develop and support quality programs including investigations and training compliance; Interface with client quality personnel to ensure requirements are followed; Perform and support audits; Manage and report on critical performance measurements; Lead staff through clear communication of expectations and continuous improvement feedback.
Seniority
Senior, hands-on IC with leadership responsibilities
