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Arrowhead Pharmaceuticals · 1 month ago

Senior Manager, Quality Assurance (Medical Device)

Verona, Wisconsin, United States

Full-time

Onsite

Senior Level, Lead/Staff

$130K/yr - $150K/yr

8+ years exp

Arrowhead Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing innovative drugs for diseases with a genetic basis. The Senior Manager, Quality Assurance will provide medical device quality assurance support and ensure compliance with relevant regulations for clinical and commercial product quality.

BiotechnologyHealth CareNanotechnologyPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc

Monitor, guide, and ensure internal stakeholders’ decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures

Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements

Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation

Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation

Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement

Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.)

Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers

Review Clinical Study Plans that include device instructions

Qualification

Medical Device Quality AssuranceQuality Management System (QMS)GxP KnowledgeISO 13485Supplier Quality ManagementMicrosoft Office ProficiencyLeadership ExperienceCommunication SkillsInterpersonal Skills

Required

BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred

Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility

Medical Device experience required

Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products