Sr. Technical Manager, Supplier Quality Management BPO
Listed on 2026-07-23
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
The Sr. Manager, QA, Supplier Quality Management BPO is an operational leadership role responsible for the execution, day‑to‑day management, and continuous improvement of core Supplier Quality Management (SQM) processes supporting Bio Marin’s external supply network for GMP/GDP materials. This role serves as the Business Process Owner (BPO) for the SQM quality process and is accountable for ensuring the processes are consistently applied, effectively monitored, and continuously enhanced across the global supplier base.
The Sr. Manager owns and executes the GMP/GDP material audit program, tracks and maintains key performance metrics for the Supplier Quality department and drives measurable continuous improvement initiatives. Additionally, this role leads the digitalization and AI enablement agenda for the department — translating strategic direction from the Director into practical implementation of automation, analytics, and AI‑enabled tools that improve efficiency, oversight, compliance and decision‑making.
The Sr. Manager also provides hands‑on support to the execution of Supplier Quality Category Manager activities, partnering closely with category managers, Procurement, and Technical Operations to ensure supplier qualification, quality agreements, changes, deviations, and performance activities are executed on time and to standard.
This position requires strong GxP execution expertise, disciplined process management, and the ability to operate effectively in a matrixed, cross‑functional environment with a focus on delivery, compliance, and operational excellence.
Responsibilities- 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.
- Coordinate 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.
- 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.
- 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.
- Lead the execution of the department’s digitalization and AI implementation roadmap, in alignment with the broader Quality Digital Strategy…
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