Manager QA
Core
Leading and directing Quality staff supporting production, ensuring compliance with quality standards and procedures in a biotechnology manufacturing environment.
Role type
Manager QA (Quality Assurance)
Builds
Medicines and clinical research products for global distribution
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Resource planning, KPI management, real-time QA oversight, compliance investigation, cGMP record review, risk alerting, audit leadership, continuous improvement, staff training, batch disposition alignment
Preferred skills
Qualified Person (QP) knowledge, GDP guidelines knowledge
Technologies
cGMP, electronic batch records, change controls, SOPs, CAPA, Deviations
Responsibilities
Manage resource planning (shift roster, holidays); Achieve Plant QA Key Performance Indicators; Provide real-time QA oversight and support for production operations; Collaborate with operations to resolve quality and compliance issues; Review and approve cGMP records; Alert senior management of quality, compliance, supply and safety risks; Participate in internal audits and regulatory inspections; Support Lean Transformation and Operational Excellence initiatives; Provide training and advice to staff; Align batch review activities with batch disposition.
Seniority
Manager, hands-on leadership