Sr Technical Consultant, Compliance

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

In this role you will schedule, plans, and coordinate compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Responsibility includes conducting internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements. Serves as the senior technical expert within department in the Quality organization and manages the results in terms of product quality and conformance to regulations and Baxter quality policies.

This role supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required and also schedules and coordinates Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes. Prepares and publishes annual product reviews and is responsible for ensuring site is ready for regulatory inspections.

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 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 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.

• Execution and management of the internal audit process and leading the audit readiness program at Round Lake Drug Delivery and Penicillin facility ensuring compliance with all applicable provisions of Baxter's Quality System, and the regulations and standards applicable to the site operations.
• Schedule and plan for the audit activity by researching background information, including previous audit results. Plan and develop assessment strategies and logistics.
• Perform internal audits, by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management.
• Drive execution and completion of key regulatory and compliance projects and initiatives.
• Evaluate corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Raise issues to management as appropriate. Track and report on commitment status through closure. Work with plant partners to ensure audit commitments are completed according to the approved timeliness targets.
• Handle the audit file through the entire process to closure. Prepare summary reports depicting results and trends for management review purposes. Ensure plant collaborators provide data in a timely manner. Ensure data is submitted on time into the MOST system for corporate level management reviews.
• Perform follow-up audits, when applicable, to confirm corrective and preventive action is effective. Ensure audit commitments are completed on time at the site.
• Train and mentor new auditors and lead the guest auditor program. Maintain the training curriculum for auditors. Provide necessary training to plant personnel to support audit readiness.
• Work with customers for services provided by Baxter Round Lake Drug Delivery. Ensure customer concerns are addressed in a timely manner.
• Support management of external inspections. Track and report the status of external commitments through closure.
• Ensures Quality Agreements or Distribution Agreements are maintained and facilitates any updates to agreements.
• Schedule and coordinate Management Review and Quality Data Review meetings, including publishing of summaries of the data presented, conclusions, and meeting minutes as required. Document and track action items and follow-up commitments to closure.
• Lead and run multiple projects/teams including corporate quality policy & procedure gap analysis and implementation, the global audit observation certification process, Annual Product Reviews, SOP and training code audits, and other quality system improvement projects.
• Remains current in regulatory trends and requirements through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, Internet, or other industry literature.
• Identify and implement continuous improvement initiatives to support improvements in complaints and overall product quality.
• Support other quality systems initiatives as required.
  

• BS in Business/Science or equivalent degree.
• At least 7 years of experience in Quality with a pharmaceutical or medical device company, or other similarly regulated industry.
• Previous auditing experience required, and ASQ and/or another accreditation is highly desirable.
• Strong interpersonal skills and attention to detail are necessary.
• Must be a team player with good problem solving, and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently.
• Computer skills/experience using MS Office, TrackWise, Cornerstone, or similar systems is highly desirable.
• Experience and knowledge of FDA, Health Canada, and other international regulations and guidances required. Must be familiar with industry standards and guidances for pharmaceutical manufacturing (USP, PDA, & ISPE).

Must not be allergic to Penicillin and Cephalosporin or their related products and /or materials

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 $128,000 - $176,000 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 and 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 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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