Director, Quality Systems - San Diego

Job Description Summary · The Quality Systems and Regulatory Staff Lead ensure robust governance and execution of post-market quality processes, including CAPA management, issue impact determinations, field action decisions and follow-ups. This role evaluates quality signals to d ...

The Information Systems & Informatics Quality Systems Manager is responsible for the ownership, oversight, and continuous improvement of enterprise Quality Systems and associated systems that support regulated business processes. · System Owner - manage electronic QMS and process ...

The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, · and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure compliance · to GMP requirements, FDA & ISO standards and other ...

The Quality Systems Specialist (Veeva) is responsible for supporting Capricor's transition to the Veeva electronic Quality Management System (eQMS) and providing ongoing system administration, configuration, and maintenance. This role plays a key part in ensuring the eQMS meets G ...

The Quality Systems (QS) Specialist I is responsible for assisting in the planning, coordination, control, · and continuous improvement of key components of the Quality Management System (QMS), which helps to ensure · compliance to GMP requirements. CAPA process: tracking and dri ...

JOB SUMMARY · This role leads Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization's growing pipeline. The role partners closely with Regulator ...

· Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne m ...

The Quality Systems Engineer plays a critical role in maintaining and improving the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., ISO13485:2016, MDSAP, EU MDR 2017/745, QMSR FDA 21 CFR Part 820). This role is responsible for leading ...

· About Acadia Pharmaceuticals · Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved t ...

The Quality Systems (QS) Specialist I plays a key role in supporting the planning, coordination, and continuous improvement of the Quality Management System (QMS). This position ensures compliance with GMP requirements, · FDA & ISO standards, · and other applicable regulations.Su ...

+ Head of Quality Systems & Compliance: responsible for providing direction and execution regarding quality systems, compliance, and quality engineering services. · Responsibilities:Drives the establishment and maintenance of the ISC quality management system · Lead strategic reg ...

· The Quality Systems Engineer plays a critical role in maintaining and improving the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., ISO13485:2016, MDSAP, EU MDR 2017/745, QMSR FDA 21 CFR Part 820). This role is responsible for leadi ...

About Acadia Pharmaceuticals · Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved trea ...

JOB SUMMARY · This role leads Quality Systems and Compliance, with responsibility for designing and implementing a Quality Management System (QMS) that supports current clinical development programs and the organization's growing pipeline. The role partners closely with Regulator ...

The IT Infrastructure Manager will be responsible for the entire lifecycle of IT infrastructure for Arrowhead across multiple sites. · Responsibilities include overseeing all IT infrastructure, designing and implementing strategic plans to ensure the company's needs are met and f ...

The IT Infrastructure Manager will be responsible for the entire lifecycle (designing, planning, purchasing, implementing, maintaining, retiring) of IT infrastructure for Arrowhead across multiple sites. This includes physical, virtual, on premise and cloud-based assets used in t ...

The IT Infrastructure Manager will be responsible for the entire lifecycle of IT infrastructure for Arrowhead across multiple sites. · This includes physical, virtual, on premise and cloud-based assets used in the support of all functions of the business. · This is a position whe ...

We are seeking a System Quality Engineer 3- Hardware Post-Market to lead investigations into hardware-related field failures. · Knowledge:Deep understanding of hardware engineering fundamentals. · Expertise in system engineering concepts. · ...

At Insmed, every moment and every patient counts — and so does every person who joins in. · ...

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, cel ...