Senior Manufacturing Manager

Baxter•Cleveland, OH

About The Position

The Senior Manufacturing Manager provides leadership and oversight to ensure quality, compliance, operational excellence, and employee engagement within the manufacturing organization. The role ensures finished products meet applicable specifications and comply with SOPs, cGMPs, FDA regulations, and regulatory commitments. The manager leads teams through subordinate leaders to achieve safety, quality, delivery, cost, and productivity objectives while meeting budgets, schedules, and operational performance targets. The position drives continuous improvement, supports the site's Manufacturing Operating System, analyzes quality and operational data, and leads resolution of complex quality and operational issues. It involves collaboration with senior leadership, cross-functional teams, suppliers, regulatory stakeholders, and other internal and external partners. The manager promotes a culture of safety, quality, accountability, and continuous improvement, maintains a clean and safe environment using 6S principles, and adheres to environmental, health, and safety requirements.

Requirements

Bachelor's degree in Engineering, Life Sciences, Operations Management, or another technical discipline.
Minimum of 8–10 years of manufacturing experience.
Minimum of 5 years of leadership experience.
Minimum of 5 years of experience in a regulated manufacturing environment.
Demonstrated ability to lead and develop teams through subordinate leaders while fostering accountability, engagement, and continuous improvement.
Strong understanding of quality systems, regulatory requirements, and manufacturing operations in a regulated environment.
Ability to analyze statistical data, operational metrics, and financial results to make informed business decisions.
Ability to identify, troubleshoot, and resolve complex technical and operational challenges.
Experience partnering with internal subject matter experts, external suppliers, and regulatory stakeholders.
Ability to prioritize multiple initiatives and manage competing demands in a fast-paced manufacturing environment.
Proficiency with Microsoft Office Suite and other business systems and software applications.
Strong verbal and written communication skills and ability to influence stakeholders at all organizational levels.
Ability to read, interpret, and apply technical documentation, work instructions, and quality procedures.

Nice To Haves

Master's degree, MBA, or other advanced degree.
Experience working within an FDA-regulated environment.
Demonstrated experience leading quality, operational, or manufacturing improvement initiatives in a highly regulated industry.

Responsibilities

Ensure finished products meet quality, safety, and efficacy standards and comply with product specifications, SOPs, cGMPs, FDA regulations, and regulatory commitments.
Lead and develop teams to achieve business objectives related to safety, quality, delivery, cost, and productivity.
Ensure budgets, schedules, and operational performance targets are achieved while maintaining quality and regulatory compliance.
Drive continuous improvement to enhance product quality, improve operational efficiency, reduce costs, and minimize customer complaints.
Partner with internal and external stakeholders to identify process-improvement opportunities and implement sustainable solutions.
Analyze quality, operational, and customer feedback data to identify trends and develop actions that improve product performance and customer satisfaction.
Support and advance the site's Manufacturing Operating System through data-driven decisions and continuous improvement methodologies.
Lead resolution of complex quality and operational issues using in-depth analysis, cross-functional collaboration, and risk-based decision-making.
Collaborate and communicate with senior leadership, cross-functional teams, and external partners about operational, quality, and regulatory matters.
Promote a culture of safety, quality, accountability, and continuous improvement.
Maintain a clean, organized, and safe work environment through consistent application of 6S principles.
Learn, understand, and apply quality standards, SOPs, cGMP requirements, and applicable regulatory expectations.
Adhere to environmental, health, and safety policies, procedures, and site-specific requirements.
Perform additional duties as assigned and work overtime as necessary to support business operations.

Benefits

Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays.
Paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.
May be eligible for discretionary bonuses.