Director, Global Device Quality

BioMarin Pharmaceutical Inc.

About The Position

The Director, Global Device Quality serves as the strategic and operational leader responsible for device and combination product quality oversight across BioMarin’s drug–device combination product portfolio throughout the product lifecycle—from early clinical development through commercialization and lifecycle management. This role defines and executes the global device quality strategy, ensuring compliance with applicable regulatory requirements (e.g., 21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366) while enabling robust design control, risk management, and verification/validation frameworks for device constituents and the combination product. This leader will provide hands on engagement on design controls, risk management, verification and validation, usability engineering, and design transfer readiness. The Director role will serve as a member of cross functional teams to embed quality by design, influence product strategy, and ensure that combination products meet internal QMS requirements, international regulatory expectations and delivers high performing device solutions that support patient needs.

Requirements

BA/BS in Mechanical Engineering, Biomedical Engineering, Quality Engineering, or related field or related field; advanced degree strongly desirable
Minimum 10 years in medical device quality or design assurance with 7+ years focused on new product development for combination products Deep working knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, and applicable global regulatory expectations
Proven experience authoring DHF content, leading V&V and test method validation, and executing complex risk management activities
Strong facilitation, negotiation, and stakeholder management skills with a history of driving decisions in matrixed teams without direct reports
Excellent technical writing and presentation skills for regulatory submissions, design reviews, and executive briefings
Proven ability to influence strategic decisions and drive accountability across organizations

Responsibilities

Serve as the Device Quality representative within the Global Quality organization, ensuring alignment on combination product quality strategy, risk posture, and key program deliverables.
Provide quality leadership across device development activities, including design control, verification and validation, risk management, and regulatory compliance.
Provide quality oversight of design control activities, including design inputs, design outputs, verification, validation, and design transfer to ensure compliance with global regulatory expectations.
Ensure effective development and maintenance of Design History Files (DHF) in accordance with FDA and global regulatory requirements.
Review and approve device verification and validation protocols and reports to ensure robust device performance and regulatory compliance.
Provide input to the risk management framework for combination products in alignment with ISO 14971, ensuring proactive identification, mitigation, and monitoring of patient safety risks associated with device components.
Provide quality oversight of human factors and usability engineering strategies to ensure alignment with regulatory expectations and user needs.
Provide quality oversight for device testing strategies including mechanical performance, biocompatibility, extractables and leachables, container closure integrity, and device-related stability considerations.
Partner with Device Engineering, Regulatory Affairs, Drug Product Development, and Supply Chain teams to ensure alignment on device specifications, control strategies, and overall product quality requirements.
Provide quality input to regulatory submissions and health authority interactions related to device constituents of combination products.
Prepare for and support internal design audits and external regulatory inspections focused on design controls and risk management.
Interface with device suppliers and external partners to influence quality practices, ensuring alignment with applicable regulations.
Maintain oversight of device-related product quality risks and ensure timely identification, mitigation, and escalation of issues to program teams and senior management as appropriate.
Lead cross-portfolio initiatives to improve device quality systems, processes, and operational effectiveness.
Be the voice of device quality in the broader BioMarin ecosystem.
Other duties as assigned.
Periodic travel is required.