Senior Manager – Quality Audits/ Audit Readiness - Round Lake, IL | Biospace
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Senior Manager – Quality Audits/ Audit Readiness

Baxter International, Inc.

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Location:
Round Lake, IL
Posted Date:
12/1/2016
Position Type:
Full time
Job Code:
160007A1
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.

This Senior Manager is responsible for supporting Baxter’s Global Internal Audit/ Audit Readiness program and well asensuring compliance to company policies, regulations and global standards.

Essential Duties and 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 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 Quality management

  • 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 as needed

  • Acts as a mentor/ coach to guest auditors and new hires
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Requirements

  • 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 and Experience


  • Bachelors Degree in Science or Engineering

  • Minimum of 7+ years of experience in Quality, Compliance, Manufacturing, Engineering or related field

  • 5 years of management experience

  • Independent Certifications desired (e.g. CQA, RAPS)

  • Experienced FDA Auditor


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Equal Employment Opportunity


Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.


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Pay Transparency Policy


Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.