Senior Quality Compliance/Audit Manager
2 weeks ago
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.
Responsible for the Audit Management system and manages the compliance program, policies, and practices of the organization according to regulatory requirements related to FDA, USP Pharmacopeia as well as any location-specific laws.Oversees internal controls and auditing systems that monitor and report on regulated activities and processes.Plan, supervises, organizes and implements all activities related to staff and direct its department.
ESSENTIAL DUTIES AND RESPONSIBILITIES:- Implements compliance program of existing procedures and controls to identify, detect, and correct noncompliance.
- Evaluates and implements changes to compliance processes due to new or amended regulations.
- Lead and deploy regulatory training initiatives.
- Support training program as to promote a better understanding of Regulatory Standards. Such as: Quality System Regulations21 CFR Part 211, USP Standards, 21 CFR Part 11, 21 CFR Part 314, and other applicable regulations and standards.
- Provides input to strategic decisions that affect the functional are of responsibility.
- Plan and executes internal audit program including Corporate/Divisional audits and ensure responses and CAPA are adequate. Arranges quality systems audits, per the annual schedule (Annual Audit Assessments Schedules).
- Manages regulatory inspections such as: FDA, Canada MOH.
- Lead remediation compliance program and audit readiness plan.
- Manages the Quality Site model.
- Develop and oversee site Quality Plans.
- Writes corrective actions and keeps track of them before and after internal and external inspections and audits; assures that company makes all changes necessary to comply with all regulations, standards and procedures.
- Keeps associates oriented on regulatory issues.
- Drives the team to achieve the proposed goal in compliance to all internal and external regulations and standards.
- Track and trend external regulatory observations and determine local actions according to emerging trends.
- Executes gap assessments against Baxter policies and regulatory standards.
- Determine short- and long-term plans to improve compliance at the site.
- Approve deviations investigations and provide oversight to the laboratory activities.
QUALIFICATIONS • EDUCATION and/or EXPERIENCE
Bachelor’s Degree (BS) in Sciences or Engineering, eight years or more in related field. Excellent communication skills in English and Spanish. Strong knowledge of Federal and Local regulations (such as: FDA, USP, Annex I, PICS). Computer knowledge. Experience in managing Standard Operating Procedures (SOP’s) and documentation audit programs. Excellent interpersonal skills, communications skills (verbally, written, visual). Knowledge of Microsoft Office (Word, Excel, Power Point, etc.). Knowledge in Six Sigma, Lean, and statistics are desirable.
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 . 129091 PO Box 518 Road 144 Km 20.6|Jayuya, PR 00664|United States of America #J-18808-Ljbffr-
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