Associate Director Quality

Baxter International Inc. • Saint Paul, MN

1d • $160,000 - $220,000

About The Position

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. Your Role This position is responsible for being Most Senior plant level Quality Management Representative, developing and deploying the quality system for the plant, assuring systems and procedures for regulatory compliance are established and deployed.

Requirements

• 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
• 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

Responsibilities

• Acts as the Management Representative for Quality.
• Manages the Quality organization in a mid to large size plant.
• Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion.
• Manages the batch review and release activities
• Fulfills the role of PRRC, specific to: 1. a) Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release 2. b) Ensuring Post-Market Surveillance (PMS) obligations are met 3. c) Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
• 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
• Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department.
• Manage regulatory inspections
• Periodically reviews the suitability and effectiveness of the quality system with executive management
• 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
• Develop budget for quality organization
• Department and ensures adherence to the budget
• Manages overall coaching, training, development and succession plans for the team

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level