Quality Control, Mgr

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

#ThisIsWhere

Your role at Baxter

The Quality Control Manager is responsible for providing strategic technical operational and people leadership for the sites Microbiology and Chemistry Laboratories. This role ensures compliant timely and scientifically sound execution of all laboratory activities supporting product quality patient safety regulatory compliance batch disposition and uninterrupted supply.

The position oversees laboratory operations environmental monitoring analytical testing contamination control programs microbiological and chemical investigations data integrity inspection readiness laboratory performance talent development and continuous improvement initiatives. The role serves as the primary quality laboratory subject matter expert and collaborates closely with Quality Assurance Manufacturing Engineering Validation Technical Services Regulatory Affairs Supply Chain and Global Quality to proactively identify and mitigate quality and compliance risks.

What youll be doing:

• Lead daily operations of the Microbiology and Chemistry Laboratories ensuring timely execution review and approval of testing activities.

• Ensure laboratory testing supports product disposition batch release manufacturing operations regulatory commitments and supply continuity.

• Manage laboratory resources staffing workload prioritization capacity planning and performance objectives.

• Ensure all testing is performed in accordance with approved methods specifications procedures sampling plans regulatory filings and cGMP requirements.

• Maintain laboratories in a continuous state of inspection readiness for regulatory inspections customer audits internal audits and corporate assessments.

• Ensure laboratory documentation calculations records electronic data and audit trails comply with data integrity requirements.

• Provide technical leadership for microbiological and analytical quality systems laboratory controls instrumentation contamination control strategies sterility assurance programs environmental monitoring utility monitoring and analytical methodologies.

• Support analytical method validation verification transfer implementation and lifecycle management.

• Oversee qualification calibration maintenance troubleshooting and lifecycle management of laboratory equipment and computerized systems.

• Ensure laboratory systems chromatography platforms electronic laboratory records and data management processes remain compliant and effective

Investigations & Risk Management

• Lead microbiological and analytical investigations related to OOS OOT deviations contamination events environmental monitoring excursions sterility failures utility excursions equipment failures and data integrity concerns.

• Drive root cause analysis quality risk assessments CAPA development effectiveness verification and continuous risk mitigation activities.

• Ensure timely escalation and management of risks that may impact product quality patient safety regulatory compliance or supply continuity.

• Support quality risk assessments for manufacturing processes facilities equipment utilities product changes validation activities and process improvements.

Cross-Functional Partnership

• Partner with Manufacturing Engineering Validation Technical Services Regulatory Affairs and Quality Assurance to support product quality decisions and operational excellence.

• Support aseptic processing controls cleanroom operations contamination control programs facility expansions process validations cleaning validations equipment qualifications and new product introductions.

• Participate in technology transfers product lifecycle management stability programs and continuous improvement initiatives.

Operational Excellence & Business Performance

• Establish and monitor laboratory performance metrics including turnaround times environmental monitoring trends investigation cycle times right-first-time performance compliance indicators and productivity measures.

• Develop laboratory dashboards performance reports capacity assessments and improvement plans.

• Lead Lean Laboratory initiatives to improve workflow efficiency reduce cycle times eliminate non-value-added activities and optimize resource utilization.

• Drive adoption of automation laboratory digitization electronic systems and innovative analytical technologies to improve efficiency data quality and cost effectiveness.

• Manage laboratory budgets forecasting resource planning and cost optimization initiatives.

• Develop business cases and ROI assessments for laboratory investments automation projects and technology upgrades.

What youll bring:

• Bachelors degree in Microbiology Biology Biotechnology Chemistry Biochemistry Pharmaceutical Sciences Chemical Engineering Life Sciences or related scientific discipline required.

• Masters degree or other advanced scientific qualification preferred.

• Advance level of English

• Minimum of 7-10 years of progressive experience in Quality Control Microbiology Analytical Chemistry Pharmaceutical Manufacturing Biotechnology Medical Devices Healthcare Manufacturing or other regulated industries.

• Minimum of 3-5 years of leadership experience managing laboratory operations technical teams or quality organizations.

• Proven experience supporting regulatory inspections customer audits compliance remediation and inspection readiness programs.

• Experience leading microbiological and analytical investigations contamination control strategies environmental monitoring programs quality risk management activities and CAPA systems.

• Strong background in cGMP laboratory operations quality systems method lifecycle management equipment qualification and data integrity requirements.

#LI-GR1

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

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.