Sr. Quality Technical Consultant – Pharmaceuticals Segment

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. 

Your role at Baxter

We are seeking a highly skilled and detail-oriented Product Quality Authority with a strong background in sterility assurance to join our pharmaceutical team. The ideal candidate will play a meaningful role in ensuring the quality, safety, and compliance of pharmaceutical products, particularly in aseptic manufacturing environments. This role requires in-depth knowledge of sterility assurance principles, regulatory requirements and quality systems.

Serves as authority for Product Quality department supporting Pharmaceuticals Segment with support on business development projects. Is responsible for results in terms of product quality and conformance to regulations and Baxter quality policies. 

What you will be doing:

• Lead all aspects of aseptic processing and sterility assurance activities for development projects, ensuring compliance with Good Manufacturing Practices (GMP) and other relevant guidelines.
• Develop, implement, and lead contamination control strategies, including environmental monitoring, cleanroom qualification, and risk assessments.
• Review and approve sterility assurance protocols and reports for validation, including sterilization processes, aseptic filling, and media fill studies.
• Serve as an authority (SME) during regulatory inspections and audits, addressing sterility assurance and quality concerns.
• Serve as the technical authority within Product Quality supporting the Pharmaceuticals Segment with responsibility for results in terms of product quality, performance and safety.
• Collaborate with multi-functional teams, including manufacturing, engineering, and regulatory affairs, to ensure product quality.
• Product Quality representative on product teams supporting business development. Specialized in product development process to ensure product is safe, effective, and meets regulatory requirements through the design lifecycle
• Strong process knowledge of product to be able to review and challenge product design and risk management life cycle activities and drive post market continuous improvement.
• Support Baxter Site and External Contract Manufacturers as needed as product knowledge experts including complaints, APQR, batch release, NCR, SNC, and field actions.
• Implement the quality systems procedures and manage compliance in product quality. Support QMS improvement initiatives.
• Understands and assures conformance to regulations in supporting Product Quality within Pharma segment. Interfaces with regulators during inspections.
• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
• Interact frequently with leaders and functional peer group of technical specialists.
• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Serves as a mentor, trainer & supports development of more junior associates.

What do you bring:

• BS in science or engineering, advance degree
• 7+ years experience in Quality, Manufacturing, Engineering or related field.
• Detailed knowledge of applicable procedures, specifications, regulations and standards.
• Proficiency in cleanroom design, construction, and operation.
• Experience in conducting sterility testing, including media fill studies, bio-burden testing, and other microbiological testing.
• Familiarity with risk assessment and control strategies in sterile manufacturing
• Experience in leading and executing sterility assurance programs, including development, validation, and implementation of procedures.
• Perform risk assessments related to sterility assurance, identify gaps, and implement corrective actions.
• Experience in leading and participating in investigations into quality issues, root cause analysis, and implementation of corrective and preventive actions
• Strong analytical and problem-solving skills.
• Ability to mentor and serve as an internal technical guide.
• Strong communication and leadership skills.
• Strong interpersonal/communication/influencing/negotiation skills.
• Strong project management skills.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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/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.

#LI-AR1

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.