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. Your Role at Baxter 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. Your Team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing 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 What You'll Bring BS m 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 In depth knowledge of the regulatory environment for manufacture of medica 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 dec1s1on-mak1ng 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 rrncrob1ology w1th1n a GMP environment Quality expertise on tech transfer Comfortable and capable of gowning not an ISO 711SO 8 manufacturing environments. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.” US Benefits at Baxter (except for Puerto Rico)