Superintendent, Compliance

1001 Baxter Healthcare Corporation; United States; Presencial; USD 90.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and dental coverage

401(k) retirement plan

Paid time off 20–35 days

Descripción de la vacante

Baxter is seeking a Manufacturing Compliance Superintendent to lead CAPA writers and investigators, improving the quality system and preventing nonconformances. You will report to the Manufacturing Compliance Site Lead and guide a team to ensure timely closures and regulatory readiness.

Responsibilities include strengthening procedures, risk assessments, trend reviews, and interactions with auditors while partnering with cross-functional teams to sustain compliant operations across the site.

Formación

• Experience in quality systems management and remediation activities.
• Strong knowledge of cGMP, ICH guidelines, pharmacopeial standards.
• Experience leading a team of subject matter experts.

Responsabilidades

• Ensure nonconformance and exceptions are initiated and completed timely.
• Develop, implement, and maintain procedures to ensure regulatory compliance and improve execution.
• Provide strategic leadership for batch release and related control systems.
• Design updates to procedures and controls and oversee investigations and CAPAs.
• Interface with auditors and collaborate with cross-functional teams to maintain documentation.
• Assist the site Quality Compliance Lead in implementing regulatory compliance initiatives.

Conocimientos

Quality assurance

Regulatory knowledge

People management

Audit readiness

Communication

Cross-functional collaboration

English/French bilingual

Educación

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Herramientas

TW8

Quality management software

Descripción del empleo

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride. At Baxter, we are passionate about saving and sustaining lives by finding solutions to complex problems. Every single day, the manufacturing team strives to build quality products for our customers—and are oftentimes met with unforeseen problems to solve. The talents at Baxter meet these challenges head‑on, as a team, in an effort to build products with the customer’s needs top‑of‑mind. You are creative, detailed, and a heads‑down doer! You adopt a challenge and truly apply the collaborative powers of your team to produce excellent results. You are motivated by work that is never the same from one day to the next. 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. Then this opportunity is for you!

Your team at Baxter As Manufacturing Compliance Superintendent, you will report to the Manufacturing Compliance Site Lead, leading a team of CAPA writers and investigators intent on improving execution of the quality system as well as improving existing processes and identifying solutions to prevent further nonconformances and exceptions.

What you will be doing

• Your primary responsibilities include ensuring nonconformance and exceptions are initiated and completed timely.
• The output of those records and trend reviews will focus on developing, implementing, and maintaining procedures and systems to ensure compliance with regulatory requirements in addition to improving execution and reducing nonconforming events as a strategic approach to the role.
• You will provide strategic leadership for batch release (focused on records holding batches), control systems, documentation updates, investigations and the output CAPAs associated with process gaps or improvements to reduce and improve the quality of the site.
• Your role involves designing and delivering comprehensive updates to existing procedures and controls, or deploying processes to assure conformance to regulations, conducting risk assessments, establishing trend reviews, interfacing with auditors and overseeing and reviewing investigations, collaborating with cross‑functional teams, analyzing performance indicators, and maintaining comprehensive documentation of compliance activities.
• Supporting the site Quality Compliance Lead by working together to find efficient means to implement and improve regulatory compliance initiatives and complete timely audit Reponses.

Qualifications

• Bachelor’s degree or equivalent experience in Chemistry, Pharmaceutical Sciences, or a related scientific field is required.
• Minimum of 5 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry.
• Minimum 2-5 years of experience managing people.
• In-depth knowledge of relevant regulatory requirements, including cGMP, ICH guidelines, and pharmacopeial standards.
• Proven track record of successfully managing and implementing quality systems initiatives, including process improvements and compliance remediation activities.
• Experience with electronic document management systems (e.g., TW8) and other quality management software tools is desirable.
• Experience with regulatory inspections and preparedness.
• Experience leading a team of experts and supporting, mentoring, and developing team members.
• Ability to strictly adhere to dedicated timelines.
• Excellent written and verbal communication, presentation, and facilitation skills.
• Strong negotiation skills and significant experience interacting with regulatory authorities.
• Risk identification and problem‑solving skills.
• Demonstrated ability to lead, mentor, and develop others for future growth and development.
• Established relationships with regulatory authorities.
• Ability to understand verbal and written safety and quality instructions and read and comprehend written work instructions, including words and drawings.
• Proficiency in English and French written and oral communication skills, adequate to communicate with other team members.
• Demonstrated strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate and influence collaborators at all levels of the organization.

The estimated base salary for this position is $90,000 - $115,000 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.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters.

• 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.

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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.