Senior Associate, Clinical Compliance
About The Position
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. This position will report to the Associate Director, Clinical Compliance. In this role you will be a key member of the Clinical Compliance team and work cross-functionally within the Kite Development Operations organization to proactively identify risk, mitigate noncompliance, and support inspection readiness activities.
Requirements
- Master’s and 3 years of relevant experience OR Bachelor’s and 5 years of relevant experience
- Knowledge of international GCP regulatory requirements and applicable national regulations (e.g., FDA, MHRA, etc.)
- Basic understanding of deviations, CAPAs, and risk management in clinical trials
- Excellent communication skills, able to provide clear and concise instructions
- Critical and creative thinking to be able to resolve complex problems
- Ability to develop innovative solutions to maximize efficiency
- Ability to prioritize and adjust workload with guidance
Responsibilities
- Collaborate with Development Operations through all stages of clinical trial conduct to ensure GCP compliance; this includes but is not limited to the implementation of procedures and study documents and support of sponsor oversight activities
- Support the audit response process for Development Operations and follow CAPA commitments to completion
- Support global inspection readiness activities
- Support risk management activities
- Support Development Operations in noncompliance reporting and CAPA development
- Support and participate in internal audits and regulatory authority inspections as needed
- Support internal compliance assessments, including reporting of results to functional area leadership, initiating deviations, and managing associated CAPAs
- Analyze compliance data, create metrics, identify trends, and clearly communicate findings and recommended actions to management and stakeholders
- Support efforts to increase compliance awareness and a culture of compliance; includes but is not limited to leading office hours, presenting lessons learned and important compliance updates
- Support process and training compliance, including but not limited to bi-annual reconciliation of process communications
- Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to support Development Operations alignment
- Lead by example to champion quality and compliance across the Development Operations organization
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
