Job Description

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 responsibilities are clearly defined and regularly reviewed.
• Support affiliates and sites with standardized agreement templates.
• Monitor execution status and renewal requirements.
• Supplier Risk Management & Qualification
• Ensure execution of Supplier Risk Ranking Tools (RRTs).
• Monitor supplier risk profiles and audit frequency requirements.
• Review supplier risk trends and recommend mitigation actions.
• Ensure risk assessments are appropriately documented and maintained in QF.
• Support risk-based supplier qualification decisions.
• Continuous Improvement & Digitalization
• Drive simplification and standardization of supplier quality processes.
• Promote effective use of Quality Forward, digital workflows, dashboards and metrics.
• Identify opportunities to reduce manual activities and improve process efficiency.
• Lead lessons learned and process improvement initiatives arising from audits, supplier issues and inspection findings.
• Establish and monitor KPIs related to supplier qualification cycle time, audit execution, QTA completion, CAPA closure, overdue actions, supplier risk levels and compliance performance.
• Stakeholder Management & Inspection Readiness
• Act as primary QSSC contact for supplier quality activities.
• Partner with Procurement, Supply Chain, Manufacturing, Regulatory Affairs, Quality Systems and Site Quality.
• Support health authority inspections and internal audits involving outsourced activities.
• Ensure supplier qualification and audit documentation is inspection ready at all times.
• Technical Approval & Quality Oversight
• Act as designated QSSC quality approver for Third Party qualification records, Quality Agreements, Risk Ranking Tools and associated supplier quality documentation within delegated authority
• Perform final review of Supplier Risk Ranking Tool (RRT) assessments and challenge risk classification, audit frequency and proposed mitigation actions where required
• Perform final review and approval of Quality Technical Agreements (QTAs) prior to routing to relevant site, affiliate or supplier stakeholders.
• Review and approve creation, update, qualification, suspension, or discontinuation activities associated with Third Party records in Quality Forward in accordance with approved procedures.
• Review and approve Quality Forward records related to supplier lifecycle activities, ensuring completeness, accuracy and compliance of supporting documentation
• Review audit outcomes, paper assessments, supplier qualification documentation and CAPA proposals before escalation to responsible Quality functions
• Ensure supplier qualification decisions, audit recommendations and risk assessments are appropriately documented, justified and inspection ready.
• CAPA Management & Supplier Effectiveness Monitoring
• Review and approve CAPA plans resulting from supplier audits, paper assessments, Quality Agreements reviews, supplier quality events and risk evaluations.
• Ensure CAPAs are assigned, tracked and escalated through to closure within agreed timelines
• Review objective evidence supporting CAPA completion and effectiveness verification.
• Monitor recurring audit findings, repeat deficiencies and supplier performance trends and recommend additional mitigation activities when required.
• Maintain oversight of supplier quality performance metrics and CAPA effectiveness indicators.
• Review supplier quality performance trends including audit findings, complaints, delivery performance, recurring CAPAs and regulatory observations to identify suppliers requiring enhanced oversight.

OTHER RESPONSIBILITIES

QUALITY

• Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE*

*) country specific

• The employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents.

SUSTAINABILITY

• Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet

MANAGERIAL POSITIONS REQUIRE:

• Good communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project/acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking.

COMMUNICATIONS & WORKING RELATIONSHIPS

Internal

• Communicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and shared services

External

• Communication with External suppliers.