Director, Global Device Quality
BioMarin Pharmaceutical Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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.
Requirements
- BA/BS in Mechanical Engineering, Biomedical Engineering, Quality Engineering, 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.
Benefits
- Equal Opportunity Employer/Veterans/Disabled
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
design controlverification and validationrisk managementregulatory complianceDesign History Filesbiocompatibilityextractables and leachablescontainer closure integritydevice testing strategiestechnical writing
Soft Skills
leadershipfacilitationnegotiationstakeholder managementcommunicationinfluenceaccountabilitypresentation skillscross-portfolio collaborationdecision driving