Clinical Quality Manager
Location:
Round Lake , Illinois
Posted:
October 19, 2017
Reference:
17000786

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; peritoneal nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Description

The Clinical Quality Manager should have at least eight years Clinical Quality experience with Clinical Trial management experience. The position is responsible to proactively anticipate the horizon of regulations to ensure that Baxter's current GCP/Clinical Trial practices reflect current and future industry practice. This person has the responsibility to plan quality assurance activities for Clinical Trials including all Phase of Clinical trials including Post market clinical studies. This person is also responsible for ensuring Clinical processes are conducted in accordance with guidelines, all regulations and Baxter processes. This position must keep up to date with related quality legislation and compliance around clinical trials. This person may lead auditing activities to ensure that studies are conducted in accordance with GCP sponsor protocols, industry guidelines, and agency regulations. Collects quality metrics around Clinical Trial processes. The position identifies and assesses regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices. This position serves as a quality consultant for Clinical Trials, interprets Clinical Trial regulations, answers questions and makes recommendations. This person may act as auditor/lead auditor for assessments including clinical site audits and vendor audits. Drives process improvements and initiatives in support of continuous process improvements.




Essential Duties and Responsibilities:
  • Plans and monitors quality activities for Clinical Trials
  • Proactively anticipate the horizon of regulations and make sure that current GCP/Clinical Trial practices reflect current and future industry practice
  • Performs Clinical site / vendor audits as required
  • Provides Clinical quality leadership regarding, interpretation of clinical regulations, answers questions, able to make quality recommendations to Clinical Operations as required. Provides Clinical Quality leadership, expertise, and support.
  • Maintains current and leading edge expertise in quality management systems and quality techniques
  • Maintains a high level of expertise in current regulatory requirements and technical issues
  • Serves as interface for inspections audits and inspections relating to GCP compliance
  • Assist in collecting Quality metrics



Essential Duties and Responsibilities:
  • Plans and monitors quality activities for Clinical Trials
  • Proactively anticipate the horizon of regulations and make sure that current GCP/Clinical Trial practices reflect current and future industry practice
  • Performs Clinical site / vendor audits as required
  • Provides Clinical quality leadership regarding, interpretation of clinical regulations, answers questions, able to make quality recommendations to Clinical Operations as required. Provides Clinical Quality leadership, expertise, and support.
  • Maintains current and leading edge expertise in quality management systems and quality techniques
  • Maintains a high level of expertise in current regulatory requirements and technical issues
  • Serves as interface for inspections audits and inspections relating to GCP compliance
  • Assist in collecting Quality metrics

Qualifications for this role:
  • Ability to anticipate future changes in Clinical Trial Regulations
  • Knowledge and experience in GCP, ICH, local and international regulations
  • Demonstrated ability to work independently and flexible in a fast-paced, high growth environment
  • Demonstrated strong project management skills
  • Experience leading inspection-readiness activities resulting in successful FDA inspection
  • Ability to travel both domestic and internationally as needed
  • Familiar with computer validation and 21 CFR Part 11
  • Ability to identify regulatory and quality risks and proactively identify areas of concern
  • Attention to detail as well as a crisp, clear and concise style in written and oral communications
  • Presentation experience and interpersonal skills are a must

Education and Experience:
  • Bachelor's degree in a scientific, life science, clinical or other relevant area. Advanced degree is a plus.
  • At least eight years of Clinical Quality experience with Clinical Trial management experience in a pharmaceutical/medical device company
  • Auditor, Lead Auditor, and ISO Lead Assessor training preferred
  • Membership in the Society of Quality Assurance (SQA) or American Society of Quality (ASQ) along with CQA, CQM, or CQE certification desired
  • Knowledgeable in Clinical Trial regulations domestic and international including; 21 CFR Parts 50, 54, 56, 58, 312 & 812 for Clinical Trials
  • Also knowledgeable with ICH E6 Good Clinical Practice

A Career That Matters

Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.




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.

EEO is the Law
EEO is the law - Poster Supplement
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.

A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.

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