Arrowhead Pharmaceuticals, Inc. needs to ensure medical device quality assurance support for their clinical and commercial products, complying with relevant US and ROW medical device regulations, guidance, and laws.
Requirements
- 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.
- Medical Device experience required.
- Combination Product and Supplier Quality experience preferred.
- Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet.
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.)
Other
- 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.
- Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment.
- Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels.
- Ability to consistently communicate with external parties in a professional manner.
- Ability for occasional business travel.
