Your Role
As the Quality Site Head, you will serve as the Quality Management Representative for the plant and provide leadership across all quality functions. You will partner closely with site and business leadership to ensure compliance with applicable regulations and standards, support regulatory inspections, drive quality performance, and strengthen a culture of continuous improvement.
This role offers the opportunity to influence site strategy, lead a high-performing quality organization, and play a critical role in delivering products that improve patient outcomes around the world.
Your Team
Every role within Quality makes a difference. Baxter's products reach patients worldwide. Individuals in Quality either develop new processes or solve new production challenges. They are trusted and encouraged to apply creativity. Your specific role will influence a part of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
What you'll be doingProvide overall leadership and governance for the site Quality Management System (QMS), ensuring requirements are effectively established, maintained, and continuously improved.
Serve as the site Quality Management Representative and ensure compliance with applicable regulatory, customer, and Baxter quality requirements.
Lead preparations for and management of regulatory inspections and external audits.
Establish, communicate, and monitor measurable quality objectives aligned with business and quality priorities.
Direct the planning, staffing, development, and budgeting of the site quality organization.
Ensure effective evaluation, management, communication, and documentation of product safety risks.
Maintain GMP compliance across the site and oversee critical quality systems and processes.
Review and approve quality-related procedures, specifications, records, and product disposition decisions.
Lead management review activities and provide regular updates to senior leadership regarding quality system performance and improvement opportunities.
What you'll bringBachelor’s degree in Engineering, Science, or a related technical discipline required, advanced degree is preferred.
Minimum of 10 years of experience in Quality, Manufacturing or related functions within the medical device, pharmaceutical or healthcare products industry.
At least 7 years of progressive quality leadership experience, ideally within a global organization.
Strong knowledge of FDA regulations, Quality Systems, Good manufacturing practices (GMP) and regulatory compliance requirements.
Demonstrated success leading quality organizations in complex manufacturing environments.
Experience managing multiple priorities, driving results through ambiguity, and influencing cross-functional stakeholders.
Strong understanding of manufacturing processes, product configuration, and quality system methodologies.
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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $168,000-$231,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
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US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: