Position title: External Quality Management & Supplier Compliance- Manager
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
Technical University Degree (health, pharma, technical, chemical areas are advantage)
12+ years industry experience specifically in GxP with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
Experience in supplier qualification, outsourced activity management, Quality Agreements and supplier auditing is highly desirable.
Strong experience in area of GxP related to change control, deviation, quality processes and document management.
Organizational and analytical skills associated with proficiency in quality management and continuous improvement.
Critical thinking ability and risk management and risk- based knowledge and approach.
Ability in partnering with a proactive and solution- oriented approach.
Strong skills to facilitate/optimize contribution of team members as individuals and members of a quality function
Ability to work effectively in a matrix cross-functional environment.
Strong capacity for working independently with minimal supervision.
Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)
Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.
Job Purpose: The Manager, External Quality Management & Supplier Compliance is responsible for leading the centralized Third Party Quality Management function within the Quality Shared Services Centre (QSSC). The role combines people leadership with operational ownership of supplier qualification, Third Party lifecycle management, audit coordination, Quality Agreement management, supplier risk assessment, CAPA oversight and Quality Forward administration.
Responsible for final review and approval of Third Party qualification packages, Supplier Risk Ranking Tools (RRTs), Quality Technical Agreements (QTAs), and associated Quality Forward records within delegated authority.
MAIN ACCOUNTABILITIES AND DUTIES
People Leadership Manage, coach and develop External Quality Management Specialists and Experts.
Build and maintain team capability in supplier qualification, auditing, Quality Agreements, supplier risk assessment, CAPA management and Quality Forward administration.
Define training plans, competency frameworks, succession planning and knowledge sharing within the function.
Monitor resource allocation, workload distribution and service delivery performance.
Foster a culture of quality, accountability, inspection readiness and continuous improvement.
External Quality Governance & Workstream Leadership Lead the External Quality Management workstream within QSSC.
Establish and maintain standardized processes, templates, trackers, and governance mechanisms.
Ensure compliance with corporate supplier quality requirements, GMP expectations, Quality Agreements and outsourced activity requirements.
Drive harmonization across affiliates and sites for TP management activities
Third Party Lifecycle Management Oversee creation and maintenance of Third Party records in Quality Forward.
Ensure execution of TP onboarding, qualification, update, suspension, and discontinuation activities.
Govern TP lifecycle change controls and associated documentation.
Monitor status and completeness of supplier records and qualification packages.
Drive timely completion of qualification activities and escalations.
Audit Management & Oversight Lead audit planning and audit request management.
Oversee paper assessments, desktop audits and contracted audit administration.
Monitor audit schedules and supplier audit compliance.
Support inspection readiness associated with outsourced partners and suppliers.
Quality Agreement Management Oversee preparation, review, revision and maintenance of Quality Technical Agreements (QTAs).
Ensure QTA…