Job Description
Note:
The job is a remote job and is open to candidates in USA. Immunovant, Inc. is a clinical-stage immunology company focused on developing innovative therapies for autoimmune diseases. The Director of GCP Auditing will be responsible for planning and executing the GCP audit program, ensuring compliance with regulatory standards across clinical trials and related operations. Responsibilities • Plan, organize, and conduct clinical audits as Lead Auditor to assess GCP compliance across various Clinical Investigator Sites and the company’s network of Clinical Research Organizations, Clinical Testing Laboratories, and Clinical Data Management Systems • Conduct targeted /for-cause audits to support quality investigations, scientific misconduct and potential serious breach of GCP, supporting the functional teams with identifying root cause and possible corrective/preventative actions • Collaborate with both internal and external parties to ensure audits are purpose-driven, refining audit scope as needed • Independently write-up audit reports, document and communicate findings across impacted functions within the organization • Collaborate with Clinical Quality on the preparation of study-specific risk profiles, evaluation of risks and controls related to GCP and study-specific requirements for various Clinical Investigator Sites • Maintain the Clinical Quality Audit Plan in collaboration with Clinical Quality to ensure GCP audits are effectively planned and executed in accordance with risk-based criteria • Manage and track audit and inspection observations • Track and maintain audit data /metrics using internal tools and systems • Support GCP inspection readiness activities • Serve as a resource for GCP compliance issues, offering guidance, identifying risks, and recommending mitigation strategies to stakeholders and functional teams • Escalate risks to senior management and suggest immediate and long-term solutions Skills • Bachelor's degree (scientific or healthcare discipline preferred) • 10+ years in a GxP pharmaceutical/biotech industry environment with strong practical application of GCP, solid knowledge of FDA, MHRA and EMA regulations and ICH requirements, experience with other GxP areas an advantage • 8+ years of direct auditing experience as a Lead Auditor • Experience with managing external Consultants • Excellent communication skills, with the ability to remain objective and impartial throughout audits, findings presentations and implementation of CAPAs • Ability to independently interpret and apply practical knowledge of regulations and guidelines for the immediate resolution of compliance • Culturally competent to communicate and effectively navigate cross-functional needs within multiple teams • Ability to travel both domestically and internationally • Lead Auditor Certification Benefits • Full range of medical • Dental • Vision • 401k • Unlimited paid time off • Parental leave Company Overview • Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases.
It was founded in 2018, and is headquartered in New York, New York, USA, with a workforce of 201-500 employees. Its website is Apply tot his job