Manager I Quality Global Compliance Internal Auditor
Round Lake, IL
Req ID 49033BR
Business Title
Manager I, Quality - Global Compliance Internal Auditor
Business
Global Quality
Sub-Business
Global Compliance
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
This position is responsible for supporting Baxter's internal audit program to ensure compliance to company policies and applicable regulations and standards globally.
Main Duties/Responsibilities:
•Performs Quality Management System compliance audits as a team member and/or lead as required
•Interacts with all levels of internal Management across functions and business units
•Communicates results of investigations and/or audits and internal control evaluations in reports and presentations
•Evaluates audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective action
•Resolves complex issues and escalates concerns through business and GC Management, as appropriate
•Serves as a cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issues
•As needed participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations
•Maintains all organizational and professional ethical standards, while actively advocating and monitoring compliance
•Actively supports continuous improvement of the audit program and Global Compliance
•Participates in special projects/investigations as needed
•Acts as a mentor/coach to guest auditors and new hires
Job Requirements
Desired Skills:
•Positive attitude, ethics and international values which support Baxter's values, and a healthy, high performance culture
•Language skills a plus (Spanish, Portuguese, Chinese, French, German)
•3+ years of quality compliance / auditing experience in the pharmaceutical or medical device industry highly preferred
•Manufacturing and/or operations experience a plus, especially in Biologics and/or aseptic manufacturing operations
•Familiarity with quality system, production, process, and compliance audits
•Collaborative personal and professional style is essential
•Should be very responsive, have a sense of urgency in dealing with time sensitive issues Qualifications:
•Thorough knowledge of applicable Global regulations and standards
•Must be willing to travel up to 50% both domestically and internationally
•Excellent verbal and written communication skills, including presentation skills
•Strong courage of conviction, conflict resolution, interpersonal and influencing skills
•Strong technical, analytical, judgment and problem solving skills
•Ability to build relationships across functional boundaries at multiple levels internally and externally
•Ability to independently make quick, sound decisions with limited data and execute appropriate judgment on when to escalate information
•Ability to be self-motivated and work independently within defined timelines Education/Experience:
•Bachelors Degree in Science or Engineering from an accredited college or university
•Minimum of 5+ years of experience in Quality, Compliance, Manufacturing, Engineering or related field
•Independent Certifications desired (e.g. CQA, RAPS)
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.
