Quality Site Head

Baxter International Inc. • Medina, NY

3d

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your Role at Baxter The Quality Site Head will provide leadership for development and deployment of the quality systems and integrate the Medina quality system into Baxter’s quality system. You will make an impact on patients by ensuring systems, processes, and procedures for regulatory compliance are established and deployed while serving as the Management Representative for the plant. You will strategize to ensure the measurable quality objectives and goals are met and communicated.

Requirements

• BS degree in Science or Engineering required
• 10+ years related work experience in Quality, Manufacturing, or related field in a Medical Device/Pharmaceutical Industry
• 7+ years of management level experience

Responsibilities

• Develops and deploys the quality systems (e.g., management review, CAPA, design control, process control) that help to ensure products conform to defined requirements.
• Responsible for developing strategies and detailed plans for process and system improvements, as well as acquiring staffing support to assist Medina in executing the strategies.
• Understands and deploys processes to assure conformance to regulations in a mid to large size plant, programs or department.
• Supports regulatory inspections.
• Periodically reviews the suitability and effectiveness of the quality system with executive management.
• Interacts frequently with all levels of internal management as well as across functions and business units.
• Assess and resolve potential compliance challenges and risks, partnering with R&D and Marketing to develop and implement risk mitigation plans for the quality system.
• Provide input and/or oversight to CAPA programs as appropriate, to assure the effectiveness of the Quality System within the business.
• Identify issues that may delay projects and directs appropriate corrective action.
• Continually assess and analyze all elements of the quality systems and recommend actions to improve them.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager