Clinical Services Quality Manager - Biotherapies - Hybrid at Vitalant in Rosemont, Illinois

Job Description:

Description

Join Vitalant in our mission to save and improve lives through the gift of blood and biotherapies. We are seeking a Clinical Services/Biotherapies Quality Manager to ensure the highest standards of quality and regulatory compliance across our Biotherapies operations. In this critical role, you will serve as a key resource for collections and manufacturing teams, guiding them in maintaining operational excellence and adherence to industry regulations. You will serve as QM Subject Matter Expert for cGMP/cGTP related to Advanced Cell and Gene Therapy Manufacturing activities performed by Vitalant (Biotherapies) and drive continuous improvement initiatives through data analysis, process evaluation, and performance enhancement strategies. Additionally, you will oversee all aspects of the deviation management process, ensuring compliance and excellence in every aspect of our clinical services. If you are passionate about making a difference through quality and compliance, we invite you to be part of our life-saving mission.

What to Expect

Schedule: Monday - Friday

Location: Hybrid work location working on-site in our Chicago, IL area office 3 days per week and from a work from home location 2 days per week.

• Our comprehensive total rewards support you, your family, and your future with:


• Medical, dental, and vision insurance


• 401K + 5% company match


• Tuition assistance up to $5k per year


• Free basic life and AD&D insurance


• Free short-and-long-term disability insurance


• Paid time off


• Employee Resource Groups


• Recognition and perks

• Support and mentor staff by assisting with workflow coordination, training, and development.


• Analyze deviation and operational performance data to identify trends and opportunities for improvement, leading process enhancements using industry-standard methodologies.


• Lead and participate in process mapping, change implementation, and assessment of clinical service procedures.


• Support internal audits by evaluating observations, conducting investigations, performing root cause analysis, and ensuring corrective actions are implemented effectively.


• Oversee deviation management processes, ensuring accurate reporting, root cause analysis, and timely corrective actions.


• Ensure timely submission of regulatory documents and compliance with reporting requirements.


• Duties include reviewing third party proposals, protocols, validations and procedures, Also responsible for manufacturing QA/Release activities.


• Assist in hosting external inspections, developing responses, and ensuring corrective actions are effectively implemented.


• Review documents to verify process control, including validations and proficiency testing.


• Participate in operational reviews of nonconforming products, materials, and test results, ensuring proper resolution.


• Assist in the oversight of Clinical Trial Studies, ensuring compliance and quality standards.


• Support safety management efforts by conducting safety observations and identifying areas for improvement.

Requirements

Knowledge/ Education

• Bachelor's degree or equivalent combination of education and experience required.

• Certification as a Medical Technologist or SBB preferred.

• Four years related experience in a regulated industry required. To include:
  
  
  • Two years in a quality, regulatory, and/or auditing environment.
  
  
  • Two years of clinical experience in a leadership role (clinical laboratory or apheresis setting)
  
  

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.


• Must be able to maintain confidentiality.


• Ability to work in a team environment and participate as an active team member.


• Must have proficient computer skills.


• Must have analytical, statistical, personal organization, and problem-solving skills.


• Able to organize, prioritize, and execute a variable workload and multiple priorities.


• Must have proficient computer skills.

Summary

About Us

Vitalant is one of the nation's largest nonprofit blood and biotherapies healthcare organizations, providing hospitals and patients across the U.S. a safe blood supply, specialized laboratory services, transfusion medicine expertise and world-renowned research. We have a network of 115 donation centers across the U.S. and host approximately 60,000 bl ood drives annually. Vitalant provides blood and special services to patients in more than 900 hospitals across the U.S. where millions of people depend on blood donations from our generous donors.

Vitalant is committed to fostering a diverse and inclusive workplace built on a foundation of respect, integrity, teamwork, and excellence. Through our DEI strategic plan, we create opportunities for employees of all backgrounds to feel valued, seen and heard. We believe this mission drives creativity and innovation, as employees experience an environment conducive to personal growth and career development.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to Careers@vitalant.org to let us know the nature of your request.

For more EEO information about applicant rights click here