Arrowhead Pharmaceuticals
Associate Director, QA Computer Systems Validation
Arrowhead Pharmaceuticals, San Diego, California, United States, 92189
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality and Compliance department is to provide compliance oversight of GxP computer systems and validation. A key function of the position will set the strategy and oversee Arrowhead's approach to data integrity, data governance, and computer systems validation.
This position will report to the Vice President Quality and Compliance and work closely with members of the Information Technology and Systems, Quality, and Business Partners to promote awareness and understanding of the CSV/CSA framework and controls with 21 CFR Part 11 / Annex 11, GAMP requirements, and the company's goals.
Responsibilities
Serve as an internal subject matter expert in the field of CSV/CSA and 21 CFR Part 11/Annex 11/GAMP for the GxP regulated industry and advise internal stakeholders and management on matters related to regulatory compliance and R&D electronic data integrity.
Collaborate with business partners to ensure continuous and verifiable compliance and data integrity throughout the entire information systems ecosphere and lifecycle.
Coordinate Quality input in the development and revision of GxP computer system procedures, change control, investigations, and CAPAs related to the computerized systems.
Assess and ensure overall readiness of the CSV/CSA program and computer-related systems readiness for audits and regulatory inspections.
Work in collaboration with the ISI and system owners to prioritize, develop, and implement necessary risk assessments and mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies through the system lifecycle - implementation, maintenance, change management, and decommissioning.
Coordinate Quality review and approval of validation strategy, plans, protocols, reports, and other verification/validation related documentation for GxP computer systems.
Collaborate with ISI and business partners on the development of robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards.
Proactively drive a culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders' awareness and understanding of relevant regulatory requirements and industry standards.
Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance.
Effectively manage priorities, multiple projects, and the ability to communicate with all levels of personnel.
Other duties as assigned.
Requirements:
At least 10 years of relevant experience.
Experience leading QA CSV in the pharmaceutical industry and quality organization.
Experience in EDMS, LMS, e-QMS, and ERP implementation and lifecycle management.
Experience as an effective collaborator and leader.
Experience creating policies and procedures focused on data integrity and computer systems validation.
Experience creating and presenting project plans, trainings, and other presentations for leadership.
Strong knowledge of 21 CFR Part 11/Annex 11/GAMP regulations, associated guidances, and standards.
Competent knowledge of Microsoft Office, EDMS, eQMS, LMS, and ERP suites.
Preferred:
BS or Master's degree in a relevant area.
Arrowhead provides competitive salaries and an excellent benefits package.
All applicants must have authorization to work in the US for a company.
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Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality and Compliance department is to provide compliance oversight of GxP computer systems and validation. A key function of the position will set the strategy and oversee Arrowhead's approach to data integrity, data governance, and computer systems validation.
This position will report to the Vice President Quality and Compliance and work closely with members of the Information Technology and Systems, Quality, and Business Partners to promote awareness and understanding of the CSV/CSA framework and controls with 21 CFR Part 11 / Annex 11, GAMP requirements, and the company's goals.
Responsibilities
Serve as an internal subject matter expert in the field of CSV/CSA and 21 CFR Part 11/Annex 11/GAMP for the GxP regulated industry and advise internal stakeholders and management on matters related to regulatory compliance and R&D electronic data integrity.
Collaborate with business partners to ensure continuous and verifiable compliance and data integrity throughout the entire information systems ecosphere and lifecycle.
Coordinate Quality input in the development and revision of GxP computer system procedures, change control, investigations, and CAPAs related to the computerized systems.
Assess and ensure overall readiness of the CSV/CSA program and computer-related systems readiness for audits and regulatory inspections.
Work in collaboration with the ISI and system owners to prioritize, develop, and implement necessary risk assessments and mitigation actions, aligned with evolving regulatory requirements, industry standards, and business initiatives and strategies through the system lifecycle - implementation, maintenance, change management, and decommissioning.
Coordinate Quality review and approval of validation strategy, plans, protocols, reports, and other verification/validation related documentation for GxP computer systems.
Collaborate with ISI and business partners on the development of robust policies and other guidance documents to ensure compliance with applicable laws and regulations, and industry standards.
Proactively drive a culture of compliance by drafting and disseminating written materials and training that are aimed at increasing stakeholders' awareness and understanding of relevant regulatory requirements and industry standards.
Prepare and present periodic reports and status of compliance to management, including the measures and activities to ensure compliance.
Effectively manage priorities, multiple projects, and the ability to communicate with all levels of personnel.
Other duties as assigned.
Requirements:
At least 10 years of relevant experience.
Experience leading QA CSV in the pharmaceutical industry and quality organization.
Experience in EDMS, LMS, e-QMS, and ERP implementation and lifecycle management.
Experience as an effective collaborator and leader.
Experience creating policies and procedures focused on data integrity and computer systems validation.
Experience creating and presenting project plans, trainings, and other presentations for leadership.
Strong knowledge of 21 CFR Part 11/Annex 11/GAMP regulations, associated guidances, and standards.
Competent knowledge of Microsoft Office, EDMS, eQMS, LMS, and ERP suites.
Preferred:
BS or Master's degree in a relevant area.
Arrowhead provides competitive salaries and an excellent benefits package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
#J-18808-Ljbffr