Baxter International
Associate Director, Clinical Audits (Remote)
Baxter International, Myrtle Point, Oregon, United States, 97458
Why consider this job opportunity:
Salary up to $209,000 annually Opportunity for career advancement and growth within the organization Comprehensive health and well-being benefits starting on day one Flexible paid time off ranging from 20 to 35 days based on length of service Supportive and collaborative work environment focused on saving and sustaining lives Potential eligibility for discretionary bonuses What to Expect (Job Responsibilities):
Lead the Clinical Audit Program, developing and maintaining the annual risk-based Clinical Audit schedule Conduct and report on Clinical Audits of clinical investigator sites and internal processes/systems Review Clinical Audit observation responses and ensure CAPA plans address observations effectively Interact and develop relationships with clinical research vendors' quality leaders through audits and project teams Serve as a Subject Matter Expert, providing expertise to less experienced auditors and supporting the generation of clinical Audit metrics What is Required (Qualifications):
A degree in life science or engineering discipline is required; an advanced degree is preferred 10+ years of experience in pharmaceutical and/or medical device industries, with 5 years as a Lead Auditor 2 years of experience with Regulatory Inspections Management (e.g., MHRA, FDA, EU inspections) Demonstrated ability to work as a leader with strong communication and relationship-building skills Ability to travel up to 50% of the time and accommodate time zone differences in case of remote audits How to Stand Out (Preferred Qualifications):
ASQ certification, IRCA, or other relevant auditor certification Clinical Quality assurance experience specifically in medical devices Advanced knowledge of clinical development programs and clinical trial processes Knowledge of processes related to Clinical Data Management and Biostatistics functions We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Salary up to $209,000 annually Opportunity for career advancement and growth within the organization Comprehensive health and well-being benefits starting on day one Flexible paid time off ranging from 20 to 35 days based on length of service Supportive and collaborative work environment focused on saving and sustaining lives Potential eligibility for discretionary bonuses What to Expect (Job Responsibilities):
Lead the Clinical Audit Program, developing and maintaining the annual risk-based Clinical Audit schedule Conduct and report on Clinical Audits of clinical investigator sites and internal processes/systems Review Clinical Audit observation responses and ensure CAPA plans address observations effectively Interact and develop relationships with clinical research vendors' quality leaders through audits and project teams Serve as a Subject Matter Expert, providing expertise to less experienced auditors and supporting the generation of clinical Audit metrics What is Required (Qualifications):
A degree in life science or engineering discipline is required; an advanced degree is preferred 10+ years of experience in pharmaceutical and/or medical device industries, with 5 years as a Lead Auditor 2 years of experience with Regulatory Inspections Management (e.g., MHRA, FDA, EU inspections) Demonstrated ability to work as a leader with strong communication and relationship-building skills Ability to travel up to 50% of the time and accommodate time zone differences in case of remote audits How to Stand Out (Preferred Qualifications):
ASQ certification, IRCA, or other relevant auditor certification Clinical Quality assurance experience specifically in medical devices Advanced knowledge of clinical development programs and clinical trial processes Knowledge of processes related to Clinical Data Management and Biostatistics functions We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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