Associate Director, Quality

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. 

This is the most senior plant level Quality Management Representative within the Hayward facility. The Associate Director develops and deploys the quality system for a mid to large size plant manufacturing Medical Devices and Biologics, while assuring systems and procedures for regulatory compliance are established and deployed. Will periodically review the suitability and effectiveness of the quality system with executive management as well as manage regulatory inspections.

Essential Duties and Responsibilities

• Manage the batch review and release activities
•  Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
• Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
• Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
• Assesses and advises senior management concerning acquisition targets
• Interacts frequently with all levels of internal management as well as across functions and franchises
• Manages interactions with customers and regulators concerning the quality of products, systems and processes
• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
• Develops budget for a mid to large size plant or large programs/department and ensures adherence to the budget
• Manages overall coaching, training, development and succession plans for the team

Qualifications

• In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
• Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
• Strong analytical, problem solving, and decision-making skills
• Excellent verbal and written communication skills
• Success working with multifunctional, global teams
• Excellent interpersonal/communication/influencing/negotiation skills required
• Extensive working knowledge of applicable quality and regulatory standards and regulations
• Experience in risk management, validation, analytics and microbiology, within a GMP environment
• Quality expertise on tech transfer
• Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Education and Experience

• BS in science or engineering; advanced degree helpful
• Minimum of 10 years of experience in Quality, Manufacturing or related field in the medical products industry
• 7 years management experience

#LI-BAXGEN

#IND-USOPS

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.

Qualifications: