Sr. Technical Manager, Supplier Quality Management BPO

Responsibilities

• GMP/GDP Material Audit Program Management
• Manage the end-to-end execution of the GMP/GDP material supplier audit program (outsourced), including annual audit planning, scheduling, execution oversight, follow-up, CAPA tracking, and effectiveness verification.
• Ensure audits are completed on schedule in alignment with the approved audit plan.
• Cook up internal and third-party auditors, ensuring consistent audit standards, timely reporting, and closure of audit observations.
• Ensure supplier audit outcomes, identified risks, and corrective actions are appropriately documented, trended, and integrated into Supplier Lifecycle Management and Quality Management Review processes.
• Support and represent Supplier Quality during regulatory inspections and external audits involving suppliers, providing audit program data and evidence of effectiveness.
• Business Process Owner (BPO) – Supplier Quality Management Processes
• Serve as the Business Process Owner for the Supplier Quality Management quality processes, including supplier qualification and lifecycle management, quality agreements, supplier changes, supplier deviations/CAPA, and supplier auditing.
• Proactively monitor and maintain the health of these processes and their subprocesses, ensuring consistency of application across the global supplier base.
• Maintain and update associated procedures, work instructions, templates, and training materials to sustain compliance with current and evolving global health authority requirements.
• Drive process standardization, harmonization, and simplification across sites and functions.
• Partner with Quality Systems, Compliance, and IT to ensure supporting systems and workflows enable efficient and compliant process execution.
• Performance Metrics & Continuous Improvement
• Define, track, and maintain the key performance indicators (KPIs) and metrics for the Supplier Quality department, including supplier performance, process health, audit program execution, and issue resolution timeliness.
• Establish and manage reporting cadences and dashboards to enable trending, signal detection, and timely management review.
• Identify improvement opportunities from metric trends and lead cross-functional continuous improvement initiatives to address them.
• Drive a culture of data-driven decision-making and operational excellence within the Supplier Quality team.
• Support management review processes with accurate, actionable performance data.
• Digitalization & AI Implementation
• Lead the execution of the department’s digitalization and AI implementation roadmap, in alignment with the broader Quality Digital Strategy defined by the Director.
• Identify, evaluate, and implement automation, advanced analytics, and AI-enabled solutions to improve supplier performance monitoring, risk identification, trend analysis, audit effectiveness, and process efficiency.
• Partner with IT, Quality Systems, and business stakeholders to deliver sustainable, scalable digital solutions, including requirements definition, system configuration, and change management.
• Drive effective use of Supplier Quality data by integrating information from eQMS, ERP, and external systems to generate actionable insights.
• Champion adoption of digital and AI tools within the Supplier Quality team through training, communication, and hands-on support.
• Supplier Quality Category Manager Execution Support
• Support the execution of Supplier Quality Category Manager activities across assigned material categories, ensuring timely completion of supplier qualification, onboarding, and lifecycle management tasks.
• Aid in the development and maintenance of Quality Technical Agreements with global suppliers to define quality expectations and responsibilities.
• Support risk-based approaches to identify, assess, and mitigate supplier-related risks, ensuring continuity of supply and material quality.
• Provide execution support for supplier performance management (scorecards), supplier investigations, CAPAs, and change assessments as needed.
• Collaborate with category managers, Procurement, Manufacturing, and site QA to resolve supplier quality issues and drive supplier performance improvement.
• Cross-Functional Collaboration
• Partner with Global Procurement, Manufacturing, Technical Development, site QA, and other stakeholders to ensure supplier quality requirements are executed effectively across the supplier lifecycle.
• Represent Supplier Quality in cross-functional process forums, working groups, and improvement projects.
• Promote knowledge sharing and consistent application of best practices across sites and functions.
• People & Team Contribution
• Provide day-to-day guidance, coaching, and technical mentorship to Supplier Quality team members supporting the audit program, BPO activities, metrics, and digital initiatives.
• Support onboarding, training, and capability development within the Supplier Quality team.
• Foster a culture of quality, accountability, collaboration, and continuous improvement.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
• Advanced degree (MS, PhD, MBA) desirable but not required.
• Six Sigma, Lean, or auditor certification (e.g., ASQ CQA) desirable.
• Minimum of 10 years of experience in Quality Assurance, Supplier Quality, Manufacturing, or related roles within a highly regulated industry (biotechnology, pharmaceutical, medical device, or combination products).
• Solid working knowledge of global quality and regulatory requirements (e.g., GMP, GDP, ISO standards, 21 CFR).
• Prior experience as a Business Process Owner or equivalent process ownership role within a QMS environment strongly preferred.
• Proven track record of defining and managing KPIs and delivering measurable continuous improvement outcomes.
• Hands-on experience implementing digital, automation, analytics, or AI-enabled solutions in a Quality or regulated environment strongly preferred.
• Experience working in a matrixed, global environment and driving results through influence as well as direct execution.
• Excellent communication, collaboration, and stakeholder management skills, including the ability to present data and defend approaches to senior management and inspectors.
• Strong organizational skills with the ability to manage multiple priorities and deliver on time.

Benefits

• Ireland Safety Responsibility
• Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems.
• Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.