QA COMPLIANCE LEAD - GLOBAL AUDITOR (US OR MEXICO)

Vantive.
Una nueva empresa construida con nuestro legado Baxter se ha embarcado en la separación de nuestro segmento de cuidado renal, valorado en unos millones de dólares, para convertirlo en una compañía independiente.
Vantive* se basará en nuestro legado de casi 70 años en terapias agudas y diálisis domiciliaria para ofrecer la mejor atención a las personas a las que servimos.
Creemos que Vantive no sólo reforzará nuestro liderazgo en el ámbito de la atención renal, sino que también ofrecerá un trabajo significativo a quienes se unan a nosotros.
En Vantive, formarás parte de una comunidad de personas centradas, valientes y que no se conforman con lo mediocre.
Cada uno de nosotros está motivado para ayudar a mejorar la vida de los pacientes en todo el mundo.
Únete a nosotros para revolucionar el cuidado de los riñones y otros órganos vitales.
*La culminación de la separación propuesto de Kidney Care de Baxter en una empresa independiente (que se llamará Vantive) está sujeta al cumplimiento de las condiciones habituales.
Summary We are looking for a Compliance Manager responsible for supporting Baxter's Kidney Care Segment Internal Audit and Compliance Strategy program.
Ensure compliance to company policies / regulations and standards globally.
Collaborate cross-functionally within Baxter's Kidney Care Segment functions/businesses.
Grow the auditing capability within Quality Assurance, utilizing expertise, knowledge and experience of best-practice methodologies and practices in industry.
What you'll be doing.
To succeed in this role, the candidate should have extensive auditing and/ or compliance leading experience drug and/or medical device proficiencies.
This role will require travel for audits.
Travel may also be required for inspection support and compliance visits Performs Quality Management System (QMS) compliance audits as а team member and/or lead as required Interacts with all levels of internal Management across functions and business units Communicates results of audits and internal control evaluations in reports and presentations Evaluates audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective action Resolves complex issues and escalates concerns through business and Quality Management Serves as а cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issues As needed, participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations Maintains all organizational and professional ethical standards, while actively advocating and supervising compliance Actively supports continuous improvement of the audit program and Compliance strategy Participates in special projects/investigations as needed Lead compliance activities such as best practice sharing, leading QA councils for manufacturing plants and other quality improvement initiatives Lead or participate in Audit Program Management and audit risk calculation strategy Lead or participate in Site Risk Program management and drive improvements Acts as а mentor/coach to guest auditors and new hires What you'll bring.
Detailed knowledge of applicable Global regulations and standards Minimum 5 years experience in auditing or Site Quality Leading experience in drugs or medical device company Proven multitasking, project management, and execution skills Must be willing to travel up to 50% both domestically and internationally Excellent verbal and written communication skills, including presentation skills Strong courage of conviction, conflict resolution, interpersonal and influencing skills Strong technical, analytical, judgment and problem-solving skills Ability to build relationships across functional boundaries at multiple levels internally /externally Ability to independently make quick, sound decisions with limited data and execute appropriate judgment on when to escalate information Ability to be self-motivated and work independently within defined timelines Proven understanding of quality system software (e.
.
Trackwise) Good proven understanding of Windows based applications (e.
.
Word, Excel, PowerPoint) 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 $ to $ 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.
#LI-BAXGEN The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
Nuestros productos y terapias llegan a millones de personas de todo el mundo todos los días, por lo que nos enfocamos en innovaciones transformadoras que brindan atención más acertada y personalizada a todos nosotros.
Durante 87 años y contando, hemos estado en los momentos críticos donde las ideas que salvan y mantienen vidas satisfacen a los proveedores de servicios de salud, que hacen que todo suceda.
Y ahora estamos resueltos a hacer realidad nuestra osada oportunidad de transformar la atención médica global para los próximos años.