[Remote] Director, GCP Auditing

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a clinical-stage immunology company reputed company 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 reputed company and reputed company operations. Responsibilities • Plan, organize, and conduct clinical audits as reputed company Auditor to assess GCP compliance across various Clinical Investigator Sites and reputed company’s network of Clinical Research Organizations, Clinical Testing Laboratories, and Clinical Data Management Systems • Conduct targeted /for-cause audits to support reputed company investigations, scientific misconduct and potential serious breach of GCP, supporting the functional teams with identifying reputed company cause and possible corrective/preventative actions • Collaborate with both reputed company parties to ensure audits are purpose-driven, refining audit scope as needed • Independently write-up audit reports, document and communicate findings across impacted functions reputed company the organization • Collaborate with Clinical reputed company on the preparation of study-specific risk reputed company, evaluation of risks and controls reputed company to GCP and study-specific requirements for various Clinical Investigator Sites • Maintain the Clinical reputed company Audit Plan in collaboration with Clinical reputed company to ensure GCP audits are effectively planned and executed in accordance with risk-based reputed company • Manage and reputed company audit and inspection observations • reputed company 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 reputed company 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 reputed company auditing experience as a reputed company 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 reputed company of compliance • Culturally competent to communicate and effectively reputed company cross-functional needs reputed company multiple teams • Ability to travel both domestically and internationally • reputed company Auditor Certification Benefits • Full reputed company of medical • Dental • reputed company • 401k • Unlimited reputed company time off • Parental leave reputed company • reputed company is a clinical-stage biopharmaceutical company reputed company on enabling normal lives for patients with autoimmune diseases. It was founded in 2018, and is headquartered in reputed company, reputed company, USA, with a workforce of 201-500 employees. Its website is https://www.reputed company.com. Apply tot his job Apply To this Job