Senior Manager Quality Lab

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 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 Senior Manager within the Quality Lab 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 its 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 with a product 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 theres 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.

As a Senior Manager for the Quality Lab in our Pharmaceutical Plant you will play a critical role in ensuring excellence across all quality operations. You bring a strong background in quality assurance regulatory compliance and laboratory this role you will oversee quality lab functions to support product development and compliance while ensuring the highest standards of quality control throughout our manufacturing processes.

What Youll Be Doing

• Ensure testing approval and release of materials and products meet specifications for strength identity safety purity and quality.

• Establish and maintain quality systems ensuring adherence to GMP GLP and regulatory requirements.

• Review and approve specifications SOPs validation plans and other critical documents before implementation.

• Oversee calibration of instruments and maintenance of premises and equipment to uphold quality standards.

• Lead internal audits participate in vendor and regulatory audits and contribute to management reviews for continual improvement.

• Guide investigations for OOS non-conformities and complaints; ensure timely implementation of corrective and preventive actions.

• Provide initial and ongoing training for quality personnel promoting a strong quality culture across the organization.

• Supervise Quality Control and Stability lab operations ensuring accurate results and compliance with guidelines.

• Maintain effective communication channels for quality issues and keep management informed on compliance status.

• Act as delegate for the Quality Control Chemistry Head when required.

What youll bring

• Must not be allergic to penicillin and cephalosporin drugs.

• Bachelors or Masters degree in Pharmacy Science or a related field.

• 8 years of experience in Quality Management Laboratory Management or a related area preferably in medical devices healthcare or other safety-critical regulated industry.

• 3 years provenleadership/supervisionand experience within a fast-paced environment.

• Demonstrated expertise in HPLC.

• Excellent communication analytical reasoning decision making and problem-solving skills desired.

• Ability to partner with individuals and teams build cross functional relationships.

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 $136000 - $187000 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 and/or long-term incentive. 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.

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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.

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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