Quality SME - Production & Process Controls

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

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Manager II, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role, it is sure to touch a portion 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.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

• Serve as the division Quality Compliance technical SME for production and process controls, including statistical sampling, in-process control checks, manufacturing process flows, and batch record compliance across ITP sites.
• Provide strategic and technical Quality Compliance guidance on production and process controls for sterile preparations, with a  focus on manufacturing process controls and their compliance adequacy.
• Provide specialist guidance and independent compliance assessment of visual inspection programs, including inspection methods, qualification, defect classification, acceptance criteria, sampling strategies, investigations, and inspection performance trends.
• Provide specialist Quality Compliance guidance on particulate matter prevention and control, including assessment of particulate sources, monitoring and trending, investigation adequacy, and the effectiveness of site-owned corrective and preventive actions.
• Provide specialist Quality Compliance guidance on container closure integrity testing (CCIT), including review of testing strategies, method suitability and validation, lifecycle controls, investigations, and remediation adequacy, in partnership with relevant site functions and the Sterility Assurance SME.
• Support all sites in sustaining an Always Inspection Ready state through risk-based assessments, readiness reviews, mock inspections, coaching, and timely closure of identified gaps.
• Provide direct technical support during health authority inspections, including real-time assessment of production and process control questions, evidence review, response development, and follow-up commitments.
• Lead or support technical compliance assessments and remediation oversight associated with inspection observations, regulatory commitments, significant quality signals, and systemic production or process control weaknesses; challenge whether site-owned actions are risk-based, sustainable, and verified for effectiveness.
• Independently assess end-to-end manufacturing processes for compliance with approved procedures, validated process requirements, product specifications, and regulatory expectations, and recommend actions to address identified gaps.

• Perform and lead risk-based assessments of manufacturing operations, process control systems, production practices, manufacturing documentation, and operational execution.
• Review and challenge manufacturing-related deviations, investigations, process excursions, batch failures, human error events, repeat deviations, and product impact assessments.
• Evaluate process control strategies, in-process monitoring programs, alarm management practices, and manufacturing controls to ensure consistent product quality and process robustness.

• Provide technical compliance guidance on site-owned remediation plans addressing manufacturing compliance gaps, process weaknesses, recurring deviations, and inspection observations; review their adequacy and effectiveness.
• Assess procedural adherence, manufacturing discipline, shift execution, line clearance practices, batch documentation practices, and operational GMP behaviors; identify compliance gaps and recommend improvements to accountable site functions.
• Provide independent compliance review and technical guidance on proposed manufacturing process changes and standardization, using quality risk management and process performance monitoring to assess whether controls remain adequate.

• Partner with site leadership to improve investigation quality, root cause analysis, CAPA effectiveness, and operational ownership of compliance issues.
• Conduct site assessments, manufacturing system reviews, gap analyses, and mock inspections to identify vulnerabilities and opportunities for improvement.
• Monitor manufacturing compliance performance, recurring trends, process capability indicators, and operational risk signals, escalating significant concerns as necessary.
• Coach and mentor manufacturing, quality, and technical personnel on production controls, process discipline, GMP expectations, and regulatory requirements.

• Interpret current regulatory expectations and industry best practices related to pharmaceutical manufacturing operations and process control systems, and advise site functions on compliant implementation.

What you'll bring

• Bachelor’s degree in engineering, Pharmacy, Chemistry, Life Sciences, Manufacturing, Industrial Engineering, or related technical discipline required.
• Advanced degree preferred.

• Minimum 15 years of experience in pharmaceutical quality, compliance, manufacturing, process engineering, technical services, or related technical functions, including substantial experience assessing production and process controls from a quality and compliance perspective.

• Experience in sterile manufacturing, injectable products, IV solutions, aseptic processing, biologics, or combination products.
• Deep technical knowledge of pharmaceutical production and process controls, batch execution, and production quality systems, with the ability to apply this expertise in independent Quality Compliance assessment and oversight.
• Demonstrated specialist expertise in production and process controls for sterile preparations, visual inspection, particulate matter prevention and control, and container closure integrity testing (CCIT), with the ability to provide strategic and practical technical guidance, independently assess compliance gaps, and challenge the adequacy of site-owned controls and remediation.

• Strong understanding of current global regulatory expectations applicable to pharmaceutical manufacturing, including FDA, EMA, MHRA, Health Canada, ANVISA, INVIMA, TGA, and other health authorities.
• Demonstrated experience supporting health authority inspections, regulatory responses, and remediation activities involving manufacturing and production control systems.
• Strong knowledge of:
  • Pharmaceutical manufacturing processes
  • Process control strategies
  • Batch manufacturing practices
  • Manufacturing documentation systems
  • Electronic batch records and manufacturing systems
  • Deviations and investigations
  • CAPA systems
  • Process validation lifecycle concepts
  • Change control systems
  • Quality Risk Management
  • Data integrity requirements
  • Continued Process Verification (CPV)
• Strong understanding of manufacturing execution systems, operational controls, and product lifecycle management within GMP-regulated environments.
• Ability to evaluate complex manufacturing issues, identify systemic vulnerabilities, and provide practical, risk-based recommendations.
• Strong root cause analysis, investigation, CAPA development, and effectiveness verification skills.
• Effective communication, facilitation, coaching, and influencing skills with the ability to work directly with plant leadership and cross-functional manufacturing teams.
• Ability to maintain a strong on-site presence and travel regularly among supported. manufacturing locations.

Other Duties as Assigned

Please note this job description is not designed 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 required.

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 $112,000 - $140,000 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. 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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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