- Establish and maintain the GCP QA programs, policies, and procedures.
- Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
- Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues for the assigned studies and initiatives.
- Establish the study specific audit plan; perform audits and lead a team of external quality auditors as needed.
- Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings.
- Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
- Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
- Support inspection readiness plans and activities. Act as the primary liaison with Health Authority and internal/external business partners for the assigned studies and programs.
- Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.
- Bachelors or advanced degree in Biology, Chemistry, or related field.
- Minimum 12 years of GCP/GVP Quality Assurance experience.
- Strong understanding of small molecule products with direct experience in solid oral dosage forms.
- Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
- Hands-on experience in drug life cycle management.
- A successful track record of working with service providers and CROs.
- Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
- Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
- Excellent verbal and written communication skills.
- Collaborative, analytical and interpretative skills.
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others. Prior management experience is required.
- Previous experience in successfully leading assigned activities within cross-functional teams.
- Some travel required.
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Director, Clinical Quality Assurance - South San Francisco, United States - Alumis Inc.
Description
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases.Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
Alumis is hiring a Clinical Quality Assurance Director, reporting to the Sr. Director GCPQA.The role works closely with the Quality leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies.
This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.
The Clinical QA Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools, and risk mitigations.
The Director will be responsible to establish Key Performance Indicators and Metrics to trend and track on the health of the clinical trials.
The role is responsible for providing operational quality guidance for the development teams and support the Sr. Director of GCP Quality in building the Alumis Quality organization strategy and vision.This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management.
The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities.
Essential Duties & ResponsibiltiesThe salary range for this position is $220,000 - $235,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices.
Alumis Inc. is an equal opportunity employer.
Director, Clinical Quality Assurance professionals in South San Francisco
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Blake Green
Battery Technician