Director of Quality (QMR)

Company: Baxter
Location: Cleveland
Posted on: June 13, 2021

Job Description:

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.

Understand, implement, maintain, and continually improve the effectiveness the Baxter Quality Management System for the Cleveland Solutions and Devices plant. Assure systems, processes, and procedures for regulatory compliance are established and deployed. Ensure compliance to applicable standards and regulations. Manage regulatory inspections. Serve as the Quality Management Representative for the plant. Ensure that measurable quality objectives and goals consistent with the quality policy are established and communicated. Directly and through subordinates develop and manage the planning, staffing, training and budgeting for the quality organization.

Reporting to the VP, Quality - America's Solutions, this is a high visibility role that's become available due to internal promotion.

Key Duties:

• Serve as the site Quality Management Representative (QMR) - leading internal and external audits from various agencies including the FDA
• Ensuring quality and regulatory compliance
• Managing regulatory inspection
• Developing and deploying the quality systems
• Ensuring the quality system processes are effectively established and maintained in accordance with applicable regulations, standards, and Baxter Quality System requirements.
• Reviewing and assessing the suitability and effectiveness of the quality system.
• Trending and performing data analysis
• Coaching, training, and developing the quality team
• Responsible for the outgoing, safety, quality, and efficacy of all finished products manufactured at the site
• Develop, coach, mentor and ensure Quality teams are engaged and motivated to drive KPI's and site growth through efficient quality operations
• Identify innovative opportunities to create better quality outcomes
• Actively support production teams, ensuring harmony between production and quality goal

Key Qualifications:

• Strong leadership skills and demonstrated success in multi-location teams
• Player/Coach mentality - able to drive a vision and execute as needed, teaching along the way
• Active leadership around cultural and organizational change management
• Strong, proven analytical and problem solving skills
• Excellent and effective verbal and written communication skills
• Verifiable success working with multifunctional, global teams
• Excellent interpersonal communication, influencing, and negotiation skills required

Education/Experience:

• BS degree in Science or Engineering (Engineering preferred)
• Masters degree preferred
• 10+ years related work experience in Quality, Manufacturing, or related field in a pharma/solutions environment (injectables, aseptic filling, terminal sterilization or similar process/products)
• 4+ years of management level experience

Physical Demands:

Sitting/standing 8 hours per day. Light lifting may be required on occasion. Ability to gown to go into the clean rooms.

Working Environment:

Primarily office environment with frequent access to production areas, laboratories, and production floor.

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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.

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 globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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