Mgr I Quality Clinical Auditor
Round Lake, IL
Req ID 50846BR
Business Title
Mgr I, Quality - Clinical Auditor
Business
Global Quality
Sub-Business
Global Compliance
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Development, execution and maintenance of internal and external clinical study management function GCP/GLP audit schedules according to the needs of the Baxter Global Medical and Clinical Affairs and Global Compliance organizations Promoting collaboration across cross functional teams to ensure consistent performance and identification of best practices to assure Baxter's clinical program execution is compliant •Conduct audits to assure compliance to Policies, SOPs, GCPs/GLPs, regulatory guidelines and expectations for Baxter clinical program management and data integrity •Partnering with Purchasing and Supply Management (PSM) and Global Clinical Affairs to ensure alignment in the identification of compliance risks associated with new product development projects •Responsible for managing, mentoring and developing less-experienced GCP auditors
Job Requirements
Qualifications:
•Thorough knowledge of applicable procedures, specifications, regulations and standards
•Strong analytical and problem solving skills
•Ability to manage/supervise a team of employees
•Good communication and leadership skills
•Good interpersonal/influencing/negotiation skills
•Good project management skills Education and Experience:
•Bachelors Degree in science or engineering
•5+ years of experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience Preferred Qualifications:
•Experience in the Pharmaceutical and/or Medical Device industry
•Effective presentation skills
•Demonstrated subject matter expertise in GCP/GLP regulations and industry guidelines
•Experience with clinical data management and collection
•ASQ Lead Auditor and/or CCRC/CCRA certification
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
