Arrowhead Pharmaceuticals, Inc.
Senior Manager, Quality Assurance (Medical Device)
Arrowhead Pharmaceuticals, Inc., Madison, Wisconsin, United States, 53706
The Position
The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws.
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.
Requirements:
* 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. Combination Product and Supplier Quality experience preferred. * 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.
Preferred:
* 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. * Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. * Ability for occasional business
The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws.
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.
Requirements:
* 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. Combination Product and Supplier Quality experience preferred. * 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.
Preferred:
* 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. * Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. * Ability for occasional business