Quality System and Compliance lead

Marsa, Malta Island
Permanent
Full-time

5 days ago

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.Summary:Responsible for leading quality compliance initiatives that drive continuous improvement, inspection readiness, and global QMS alignment.Essential Duties and Responsibilities:

Collaborates with site Quality, segments, and other internal stakeholders to resolve compliance issues, maintain global compliance, and ensure inspection readiness
Stays current with global regulations and supports sites to ensure compliance to global regulatory requirements and Baxter’s QMS
Provides site/legal manufacturing support for ISO, MDSAP and MDR certification
Assumes project management responsibilities for assigned regulation and standard changes
Assumes project management responsibilities for assigned plant compliance support
Assumes SME ownership of assigned initiatives, as required
Develops tools and dashboards to monitor progress to project due dates, milestones, and regulatory/business commitments
Collaborates with SMEs/Site Quality Heads/Leads to maintain project strategy and to remove and/or escalate project barriers
Reports compliance initiatives to Senior Management and Quality Strategy Team
Provides external audit support, as required

Qualifications:

Project Management experience
Strong leadership skills
Excellent verbal and written communication skills
Success working with multi-functional and global teams
Excellent interpersonal/influencing/negotiation skills
Ability to engage and motivate others
Knowledge of QMS, manufacturing operations, and country regulations/international standards
Accomplishes objectives despite obstacles and setbacks

Education and/or Experience:

Bachelor’s degree
Master’s degree (optional)
3-5 years of Quality or Operational Experience

Equal Employment OpportunityBaxter 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 AccommodationsBaxter 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 here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter 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 .

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