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Senior Clinical Operations Quality Compliance Manager
2 months ago
Bicycle Therapeutics, Inc. is in search of a skilled and collaborative Senior Clinical Operations Quality Compliance Manager to join our Clinical Operations team. This role is pivotal in ensuring adherence to regulatory standards and maintaining the highest quality and integrity within Clinical Operations.
Key Responsibilities:
1. Collaborate with various departments including Clinical Operations, Clinical Quality, and Medical Affairs to uphold compliance with established processes and regulations.
2. Engage in process improvement initiatives and support the implementation of organization-wide strategies.
3. Lead investigations into GCP quality concerns and establish effective risk mitigation strategies.
4. Oversee Clinical Operations processes, training, and readiness for inspections, while actively participating in regulatory inspections.
Compliance Support:
Provide ICH/GCP compliance assistance to Clinical Operations and stakeholders, ensuring up-to-date knowledge of guidelines and internal procedures.
Relationship Building:
Develop strong partnerships with personnel across Clinical Operations and Clinical Quality to facilitate process enhancements, risk management, and inspection preparedness.
Documentation Standards:
Ensure that Clinical Operations' standard operating procedures, forms, and templates align with best practices and adapt to the evolving needs of the organization.
Quality Event Management:
Assist in resolving quality events, deviations, and findings from audits and inspections.
Continuous Improvement:
Support the clinical operations team in conducting root cause analyses and ensuring the completion of corrective actions related to Clinical Operations.
Encourage innovative processes and technologies to enhance compliant operations.
Inspection Readiness:
Facilitate and support readiness activities for inspections within Clinical Operations, providing assistance before, during, and after regulatory inspections and internal audits.
Risk Identification:
Identify and escalate significant quality and compliance risks to leadership across Clinical Operations and Clinical Quality.
Additional Responsibilities:
Participate in due diligence activities and process improvement initiatives as directed by management.
Other duties as assigned.
