Current jobs related to Associate Director, Quality Assurance and Compliance - San Diego, California - Arrowhead Pharmaceuticals
-
San Diego, California, United States Proven Recruiting Full timeDynamic Quality Assurance and Compliance RoleAre you a seasoned professional looking for a new challenge? Proven Recruiting is seeking a highly skilled Associate Director of Quality Assurance and Compliance to join our team. This exciting opportunity offers the chance to expand your knowledge, collaborate with a skilled team, and drive impactful projects.Key...
-
Director of Quality Assurance and Compliance
4 weeks ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a Director of Quality Assurance and Compliance, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CROProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic...
-
San Diego, California, United States Simply Biotech Full timeJob Title: Associate Director of QA and ComplianceSimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key...
-
Director of Quality Assurance and Compliance
1 month ago
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing strategic plans...
-
San Diego, California, United States Simply Biotech Full timeJob SummarySimply Biotech is seeking an experienced Associate Director of Quality Assurance and Compliance to join our team. This role will be responsible for ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of our operations.Key ResponsibilitiesDevelop and implement strategic plans for quality assurance,...
-
San Diego, California, United States Proven Recruiting Full timeDirector of Quality Assurance and Compliance - CRO**About the Role**We are seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance - CRO. As a key member of our organization, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to...
-
Director of Quality Assurance and Compliance
2 weeks ago
San Diego, California, United States Sekisui Diagnostics, LLC Full timeAbout the Role:As a Director of Quality Assurance and Compliance at Sekisui Diagnostics, LLC, you will play a critical role in ensuring the quality and integrity of our products. You will oversee the development, implementation, and maintenance of quality assurance systems and activities, including the generation and review of documents used in good...
-
San Diego, California, United States Proven Recruiting Full timeTransformative Leadership OpportunityProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team as Director of Quality Assurance and Compliance. This is a unique chance to drive impactful projects, expand your GLP knowledge, and collaborate with a skilled team.Key Responsibilities:Implement an Electronic Document...
-
Director of Software Quality Assurance
2 weeks ago
San Diego, California, United States XIFIN Full timeJob Title: Director of Software Quality AssuranceWe are seeking a highly skilled and experienced Director of Software Quality Assurance to join our team at XIFIN. As a key member of our organization, you will be responsible for leading our quality assurance efforts and ensuring the delivery of high-quality software products.Key Responsibilities:Lead a team...
-
Director of Quality Assurance and Compliance
2 weeks ago
South San Francisco, California, United States Pliant Therapeutics Full timeJob Title: Director, Quality AssurancePliant Therapeutics is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. As a Director of Quality Assurance, you will play a critical role in ensuring the quality and compliance of our products, from early-stage development to...
-
Associate Director, GCP Quality Assurance Lead
2 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly experienced Associate Director, GCP Quality Assurance to join our team at BioSpace, Inc. This role will be responsible for managing the clinical quality function, ensuring GCP compliance, and collaborating with cross-functional teams to drive the success of our clinical programs.Key ResponsibilitiesDevelop and implement GCP...
-
San Diego, California, United States Arrowhead Pharmaceuticals Full timeJob Title: Associate Director, QA Computer Systems ValidationArrowhead Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that develops innovative medicines to treat intractable diseases. We are seeking an experienced Associate Director to lead our Quality Assurance (QA) Computer Systems Validation (CSV) program.Key Responsibilities:Develop...
-
Associate Director, GCP Quality Assurance Lead
2 weeks ago
San Diego, California, United States Avidity NanoMedicines Full timeJob Summary:The Associate Director, GCP Quality Assurance, will oversee the clinical quality function, ensuring GCP compliance and implementing quality management systems. This role will collaborate with various departments to ensure effective communication and working relationships.Key Responsibilities:Develop and implement GCP quality management systems,...
-
Director of Software Quality Assurance
2 weeks ago
San Diego, California, United States XIFIN Full timeJob DescriptionXIFIN is a healthcare information technology company that empowers healthcare organizations to navigate an increasingly complex and evolving healthcare landscape.Through innovative AI-enabled technologies and services, we deliver operational efficiency, interoperability, and simplicity.The company's revenue cycle management, clinical workflow...
-
San Diego, California, United States BioSpace, Inc. Full timeJob Title:Director, Quality Systems and ComplianceJob Summary:We are seeking a highly experienced and skilled Director, Quality Systems and Compliance to join our team. The successful candidate will be responsible for ensuring the quality of our products and services, and will work closely with cross-functional teams to implement and maintain quality...
-
Director of Clinical Quality Assurance
7 days ago
San Diego, California, United States BioSpace, Inc. Full timeJob SummaryThe Associate Director, GCP Quality Assurance, will oversee the clinical quality function by supporting and providing oversight of clinical trials and clinical activities, establish and manage clinical quality systems, and ensure GCP compliance.Key Responsibilities Develop, implement, and maintain GCP quality management systems, policies, and SOPs...
-
Associate Director of Quality Assurance
2 weeks ago
San Francisco, California, United States Kanvas Biosciences Full timeAbout UsKanvas Biosciences is a pioneering biotechnology company dedicated to unlocking the full potential of the microbiome. Our mission is to harness the power of microbial interactions to develop innovative treatment strategies and improve human health.Our ValuesWe attract and retain top talent. Our team is comprised of world-class scientists who share...
-
Director of Quality Systems and Compliance
1 month ago
San Diego, California, United States BioSpace, Inc. Full timeJob Title: Director, Quality Systems and ComplianceAt Avidity Biosciences, we are seeking a highly skilled and experienced Director, Quality Systems and Compliance to join our Regulatory and Quality Assurance team. As a key member of our organization, you will be responsible for ensuring the quality of our products and services, while also ensuring...
-
San Diego, California, United States Inocras Inc. Full timeJob Title: Director of Quality Assurance and Regulatory AffairsThe Director of Quality Assurance and Regulatory Affairs will play a crucial role in building and maintaining Quality Systems for a next-generation sequencing clinical laboratory. Inocras Inc., a precision medicine whole genome platform company, is seeking an experienced professional to drive...
Associate Director, Quality Assurance and Compliance
2 months ago
Arrowhead Pharmaceuticals, a leading biopharmaceutical company, is seeking a highly experienced professional to join our Quality and Compliance team as an Associate Director, Quality Assurance and Compliance. As a key member of our team, you will be responsible for providing compliance oversight of GxP computer systems and validation, ensuring the integrity of our data and adherence to regulatory requirements.
Key Responsibilities:
- Develop and implement a comprehensive strategy for data integrity, data governance, and computer systems validation
- Collaborate with cross-functional teams to ensure compliance with 21 CFR Part 11, Annex 11, and GAMP regulations
- Provide guidance and support to internal stakeholders on regulatory compliance and data integrity
- Coordinate quality input in the development and revision of GxP computer system procedures, change control, investigations, and CAPAs
- Assess and ensure overall readiness of the CSV/CSA program and computer-related systems for audits and regulatory inspections
- Work with the Information Systems and Business Partners to prioritize, develop, and implement necessary risk assessments and mitigation actions
- Coordinate quality review and approval of validation strategy, plans, protocols, reports, and other verification/validation-related documentation
- Develop and maintain robust policies and guidance documents to ensure compliance with applicable laws and regulations
- Drive a culture of compliance by creating and disseminating written materials and training to increase stakeholders' awareness and understanding of regulatory requirements
- Prepare and present periodic reports and status of compliance to management
Requirements:
- At least 10 years of relevant experience in the pharmaceutical industry
- Experience leading QA CSV in a quality organization
- Experience in EDMS, LMS, e-QMS, and ERP implementation and lifecycle management
- Strong knowledge of 21 CFR Part 11, Annex 11, and GAMP regulations
- Competent knowledge of Microsoft Office, EDMS, eQMS, LMS, and ERP suites
Preferred Qualifications:
- BS or Master's degree in a relevant area
Arrowhead Pharmaceuticals offers a competitive salary and an excellent benefit package. All applicants must have authorization to work in the US for a company.
