Associate Principal Quality Partner, Shop Floor
Core
Senior quality leadership driving compliance, risk governance, and continuous improvement across manufacturing, supply chain, and engineering operations.
Role type
Senior IC Quality Partner (Pharma/Biologics)
Builds
Quality systems, compliance records, CAPA plans, and operational change execution for GxP-regulated environments.
Domain
Pharmaceutical manufacturing and biologics production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP/cGMP compliance oversight, root cause analysis, risk assessment, cross-functional influence, quality governance, corrective action strategy, audit representation, electronic document management, regulatory interaction
Preferred skills
Shop floor quality experience, senior-level judgment, leadership through influence, analytical problem-solving, organizational skills
Technologies
Electronic document management systems, laboratory information management systems
Responsibilities
Provide strategic quality oversight for critical phases of Operations and Manufacturing; Act as a proxy for the team manager in operational discussions and escalation forums; Complete, review, and approve impact assessments for nonconformances; Act as a senior QA approver for SOPs, compliance records, NCRs, and CAPA plans; Partner with leadership to identify systemic risks and prevent recurrence of quality issues; Exercise oversight of record completion timeliness and quality; Lead corrective and preventive action strategies; Provide senior-level support for quality incident investigations; Represent Quality Assurance in internal and external audits and regulatory interactions.