Sr Quality Assurance Manager

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.

What you'll do

• Ensure compliance with Quality and Compliance requirements in relation to Good Manufacturing Practices, Good Documentation Practices and Data Integrity;
• Ensure compliance with global Quality, Safety, Delivery and Productivity metrics;
• Support in the Manufacturing area during daily routines for all manufacturing shifts;
• Ensure that decision-making is carried out in a timely manner, so as not to impact the supply of products to the market;
• Participate in the Site leadership forums: Fast Response, Zone Control, CAPA review Board and Quality Management Review;
• Develop the annual strategic planning for project establishment and team metrics;
• Perform GEMBAs for Quality Investigations, Safety or for definitions of process improvements;
• Coordinate the process of releasing batches of finished goods to market;
• Manage the people of the QA Assurance (Operations) department;
• Participate in and promote the ICare program with a focus on quality (BBQ);
• Participate and influence the automation and digitalization processes of manufacturing processes;
• Evaluate deviations in batch documentation, either on paper or electronically;
• Perform and Evaluate Routine Inspections in Production Areas and Support Areas;
• Ensure compliance verification during the process of releasing batches of finished goods;
• Ensure batch release within corporate deadlines and requirements;
• Monitor process performance indicators and act on opportunities;
• Execution of ACEs, as well as compliance with metrics and action plans from ACEs or Individual Development Programs;
• Actively participate in the definition of strategies for the site;
• Represent SQH in assignments when delegated or in their absence on the site;
• Promote a quality culture  in productive processes;

What you’ll bring

• Bachelor's Degree in Biochemistry Pharmacy;
• Long term interaction with ANVISA, its Regulations and working within a pharmaceutical GMP environment.
• Fluent in English.
• Proven leadership and excellent communication skills
• Relationship skill with internal and external clients.
• Long range visibility and planning capability.

Location: São Paulo/Jurubatuba

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.

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