Manager, Quality Engineering

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.

This is where your 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.

Summary:

You will lead the Quality Engineering function providing independent oversight of the site validation program and governance of the plant data integrity program. The Quality Engineering Manager establishes strategy standards risk tolerance and performance expectations to ensure compliance with regulatory and quality requirements. You will build strong partnerships with Engineering Facilities Operations CSV laboratories and system owners to support effective program execution.

As the primary Quality representative for validation and data integrity programs you will interface with site leadership and regulatory agencies. The Quality Engineering Manager ensures validation and remediation activities are executed by accountable owners while maintaining independent Quality oversight through review approval escalation and governance.

• Establish and maintain the site strategy governance model procedures and decision rights for independent QA oversight of validation and plant-level data integrity.
• Lead develop and performance-manage the Quality Engineering team; assign oversight based on project risk complexity and business priority.
• Ensure Engineering Facilities Operations CSV laboratories and system/process owners maintain clear accountability for validation authoring and execution technical operation vulnerability remediation and sustained control effectiveness.
• Approve or delegate approval of validation master plans high-risk protocols and reports critical deviations revalidation strategies major change controls and continued use or release decisions.
• Chair or sponsor validation and data integrity governance forums; set risk-based priorities across the plant system inventory and resolve multi-functional ownership or resource conflicts.
• Ensure the data integrity program is aligned with GAMP 5 21 CFR Part 11 ALCOA principles corporate standards and current regulatory expectations.
• Review program health through metrics audits periodic reviews remediation aging deviation trends audit-trail-review performance and effectiveness checks; raise risks to site leadership.
• Ensure remediation plans have accountable operational owners appropriate milestones interim controls documented risk acceptance and independent QA verification of sustainable closure.
• Represent validation and data integrity programs in partnership with system owners during FDA and other regulatory inspections customer audits governance reviews and regulatory submissions.
• Develop capability succession plans training and standardized tools for Quality Engineering and multi-functional partners.
• Manage resources and continuous-improvement priorities to maintain compliant efficient oversight without compromising QA independence.

• Expert knowledge of cGMP validation computerized-system assurance GAMP 5 21 CFR Part 11 ALCOA principles data integrity governance quality systems and contemporary regulatory expectations.
• Demonstrated people leadership and ability to build high-performing technical teams.
• Proven capability in organizing plans making decisions considering risks governance influencing negotiation and managing conflicts.
• Ability to maintain QA independence while creating effective partnerships with Engineering Facilities Operations CSV laboratories and business leadership.
• Excellent written and oral communication skills including executive and regulatory presentations.
• Proven success leading complex programs inspections remediation governance and multi-functional organizational change.
• Working knowledge of statistics process capability risk-management tools and electronic quality systems.
• Candidate must meet all applicable site safety and occupational requirements.

• Bachelors degree in Engineering Science Computer Science or a related technical field required.
• 8 or more years of progressive experience in validation quality engineering computerized-system assurance data integrity or QA within a cGMP-regulated industry including people or program leadership.
• Prior experience participating in regulatory inspections and complex remediation programs desired.
• ASQ CQE CSQE CQA Six Sigma or comparable professional certification highly desirable.

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 $112000 - $154000 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 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.

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