Manager Quality
Core
Ensures all processes and product outputs meet quality standards for pharmaceutical products, including importation, testing, release, storage, and distribution.
Role type
Manager, Commercial Quality (GxP)
Builds
Local Quality Management Systems (QMS) and compliant supply chain operations
Domain
Pharmaceutical / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance management, Quality Management System (QMS) development, regulatory authority relations, supplier audit leadership, risk register management, market action execution, internal audit leadership, cold chain management, change control, CAPA management
Preferred skills
Stakeholder collaboration, quality culture building, cross-functional partnership, strategic planning
Technologies
GSP, GDP, cGMP, ISO9001, ISO 13485, PIC/S, ICH
Responsibilities
Manage quality operations for importation, local testing, product release, repackaging, storage, and distribution; Develop and maintain local QMS including change control, deviation, and CAPA management; Lead internal audits and self-assessments; Manage relationships with local regulatory authorities; Execute local recalls and market actions; Oversee GxP supplier management and distributor qualification; Support clinical quality assurance operations.
Seniority
Manager, hands-on leadership
