Associate Director Quality

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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.

What Youll Be Doing

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

What Youll Bring

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/or 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

We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $160000 - $220000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

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)

This is where your well-being matters. 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. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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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