Manager II, Quality Systems

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your role at Baxter:
Manage and coordinate routine activities and departments for Quality operations including Internal Assessments, CAPA, Regulatory Compliance, Customer Satisfaction (Complaints), Training Systems, the Release Department, and the Specification Department responsibilities assuring compliance with established standards and regulations. Manage procedures and associated audits assuring compliance to all government regulations, company policies and procedures. Assure the safety and quality of the products, processes, and systems.
Assesses all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance. Ensures plant FDA readiness and compliance with current Good Manufacturing Practices (cGMPs), QSRs, ISO standards, and other applicable Regulatory requirements. Coordinates all internal and external audits, assessments, and inspections (such as TUV, FDA, Global Compliance audits, and customer audits).
To assure all activities carried out are properly executed in accordance with company policies and procedures and are carried out in an expeditious and cost-effective manner maintaining compliance to FDA regulations while meeting the overall business priorities and schedules.
Your Team:
Cleveland's technology and automation are cutting edge. It is the U.S. sole source for plastic pour bottles, glass IV, and various reconstitution devices. This facility has a number of major product lines with a diverse array of automated manufacturing technologies ranging from bottle solution filling, injection molding, and device assembly.
Our Cleveland plant has been an integral part of Baxter for over 60 years. The work is challenging and rewarding, as Baxter offers competitive compensation and benefits. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
What you'll be doing:

• Identifies concerns or potential concerns to drive/ensure Quality and Regulatory Compliance within the plant. Responsible for plant compliance with all applicable corporate, divisional, local, and regulatory requirements. Ensures compliance with the Baxter Global Quality Manual and Global Processes (GQPs) and maintains the Cleveland Quality Manual.
• Serves as a key contact for the Corporate/Divisional Regulatory Affairs Groups.
• Responsible for the Internal Assessment program. Coordinates Management Review and CAPA Review Board meetings. Responsible for ensuring that all follow-up actions are addressed. Responsible for providing routine and on-going feedback to the plant SLT on assessment results. Audits, creates, and implements changes to specifications, SOPs, and forms to maintain regulatory compliance and improve the quality and manufacturing processes.
• Coordinates all external audits and Regulatory inspections. Responsible for completion of all required reports to the corporate offices for FDA Inspections per the Global Quality Processes.
• Responsible for ensuring 483 gap analyses for all Baxter-issued observations are completed in on time. Evaluates and communicates changing Regulatory requirements and 483 inspection trends with plant management.
• Serves as local CAPA Coordinator and manages the plant's CAPA System. Responsible for being the CAPA Site Coordinator and for training Cleveland employees as required on CAPA and the Trackwise System.
• Manages the local Change Control Management Coordinator, serves as a CCM facilitator, and manages the plant's CCM System. Responsible for training Cleveland employees as required on CCM and the Trackwise System.
• Responsible for the activation of all incoming Global Specifications and for changes/activation for all Cleveland generated SOPs, Job Instructions Breakdowns, and forms.
• Audits, creates, and implements changes to specifications, SOPs, and forms to maintain regulatory compliance and improve the quality and manufacturing processes. Accountable for adequacy of SOPs to assure all product meets the requirements for safety, adequacy, and efficacy.
• Manages the Complaints process from receipt to complaint record closure. Ensures compliance to global requirements.
• Ensures timely product release. Responsible for managing routine release functions and quality assurance and that these duties are performed in a timely and efficient manner.
• Manages updates for the Training system and implementation of applicable required training and training updates throughout the facility.
• Establishes and/or implements objectives/metrics for each area of responsibility.
• Must have good working knowledge of plant systems, processes, procedures, documentation, and products.
• Must be able to manage multiple tasks and projects simultaneously. Must be able to identify and implement process improvements.
• Responsible for training growth and development of subordinate(s).
• Assure that his/her staff, supervisors, and employees follow all federal, state, and company requirements, such as OSHA, EPA, FDA.
• Should be able to communicate at all Plant and Corporate levels. Works with minimum or no supervision.
• Financial responsibilities and accountabilities to include department and capital budgeting and expenditures for areas of responsibility.
• Carries out the functions of the Quality Management Representative (QMR) (in the absence of the incumbent - vacations, sick leave, business trip, etc.) as requested by QMR.
• Ability to sit, stand and/or walk for long periods of time. Ability to reach above the shoulder. Ability to bend/stoop.

What you'll bring:

• BS degree in Science or Engineering required.
• 7 or more years of experience in Quality, Manufacturing, Engineering or related field.
• 5 or more years of leadership experience.
• Certified Quality Auditor preferred.

CERTIFICATES, LICENSES, REGISTRATIONS
cGMP Training, Certified Quality Auditor - ASQ Certification, and other certificates or licenses as required.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $112,000 to $216,000 and also includes an annual incentive bonus, commission target, and/or equity target (strike any, if not applicable). The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.
DISCLAIMER STATEMENT
The above statements are intended to describe the general nature and level of work being performed by the person assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
#IND-USOPS
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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
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