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\xe2\x80\x99ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter\xe2\x80\x99s 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\xe2\x80\x94 where your purpose accelerates our mission.

Your role at Baxter:

Responsible for the Quality Operations within the business unit including development, implementation and management of plans and standards. Develop, establish and maintain quality compliance programs, policies, procedures and controls to ensure that safety, quality, identity, potency, and purity of products conform to established standards, agency regulations and guidelines, and industry compliance trends. Provide expertise and mentorship in interpreting government regulations, guidelines and internal requirements to assure compliance. Ensure that the site manufacturing operations are aligned with Baxter Quality Standards and all relevant regulatory and legislative requirements.

What you\'ll be doing:

• Implement policies to ensure ongoing compliance of regulatory requirements
• Develop and implement strategies aligned to support the manufacturing operation; including identification of gaps, resolution of discrepancies, and development of action plans.
• Expert knowledge of regulations, and experience with interpretation and application
• Assess impact of new regulations and implement appropriate changes as well as lead development of process flows and procedures.
• Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
• Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead/supervise a large team of employees
• May participate in management of budgets
• Sustain a clean and safe work area using 6S principles
• Understand, apply and implement detailed quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

What you\'ll bring:

• Advanced degree or country equivalent in related scientific field with 15 years shown experience in Quality Operations / Quality Assurance including at least 7 years proven track record handling people. Master degree or PhD in relevant field will be an advantage.
• Excellent written and verbal communication, presentation, and facilitation skills\xc2\xb7 Strong negotiation skills and significant experience in interacting with regulatory authorities
• Expert knowledge of FDA and other regulatory requirements (e.g. Eudralex, PICs, WHO) for pharmaceutical manufacturing
• Operations experience within aseptic manufacturing and terminal sterilization environments
• Solid understanding and experience using multiple statistical process control methodologies
• Knowledge and application of Six Sigma and Lean manufacturing concepts and principles
• Strong analytical and problem-solving skills, with the ability to identify areas for improvement and develop effective solutions
• Shown ability to handle, mentor, and develop others for future growth and development
• Established relationships with regulatory authorities
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to connect with other team members.

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 $128,000 to $252,000 and also includes an annual incentive bonus. 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.

Other Duties as Assigned

Please note this job description is not crafted to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as the need arises.

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.

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 here and let us know the nature of your request along with your contact information.

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