- Location
- CO/CAL - Cali, Colombia
- Type
- Full-time
- Department
- Legal
- Seniority
- Manager
- Experience
- 5+ years
- Closing date
- Today
- Source
- Workday
Description
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.
This is where your work makes a difference!
Your role at Baxter:
Maintain and sustain an effective Quality and Regulatory Compliance System at the Baxter Cali site, ensuring compliance with applicable regulatory requirements, Baxter's global corporate policies, and Good Manufacturing Practices (GMP). Lead the implementation, maintenance, and continuous improvement of Compliance processes to protect product quality, patient safety, and business continuity.
What you will be doing:
Develop, implement, and maintain quality system policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA and EMA regulations, when applicable.
Provide strategic leadership and oversight for quality system management, including, but not limited to, document control, change control, deviation management, CAPA, training, and audits.
Training and Education: Design and deliver comprehensive compliance training programs for employees at all levels to promote awareness of compliance obligations and foster a culture of integrity and ethical conduct throughout the organization.
Understand and implement processes that ensure regulatory compliance within a medium-to-large manufacturing facility or a large program/department. Manage regulatory inspections and interactions with health authorities.
Risk Assessment and Mitigation: Conduct regular assessments to identify potential compliance vulnerabilities and develop strategies to effectively mitigate risks. Monitor changes in laws, regulations, and industry trends to proactively anticipate and address emerging compliance issues.
Monitoring and Auditing: Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify opportunities for improvement. Lead and participate in internal and external audits and inspections, ensuring timely responses and resolution of findings and observations.
Investigations and Remediation: Lead investigations related to compliance incidents, misconduct allegations, or policy and regulatory violations. Implement corrective actions and remediation plans to address identified issues and prevent recurrence.
Collaborate cross-functionally with departments including Quality Assurance, Regulatory Affairs, Manufacturing, and Research & Development to drive continuous improvement initiatives and ensure alignment with quality objectives.
Monitor key performance indicators (KPIs), data analysis, and metrics to assess the effectiveness of quality systems and identify areas for improvement.
Stay current on regulatory developments, industry trends, and best practices related to quality systems, and proactively implement necessary changes to maintain compliance and enhance operational efficiency.
Regulatory Reporting and Documentation: Prepare and submit regulatory reports and filings as required by regulatory authorities. Maintain accurate and complete documentation of compliance activities, including policies, procedures, training records, and audit findings.
What will you bring?
Minimum of 5 to 7 years of experience in Quality Assurance, Compliance, or Quality Systems Management within the pharmaceutical industry, with progressively increasing levels of responsibility.
Minimum of 3 to 5 years of people management experience, including leading, developing, and coaching teams to achieve quality and compliance objectives.
Advance level of English
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.
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.
