Senior Manager Quality Management System - Facilities Production Process Test Controls
Senior Manager Quality Management System - Facilities Production Process Test Controls
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$ 136000 - 187000
1 Vacancy
Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 where your creativity addresses challenges
You are creative thorough and a headsdown doer. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Senior Manager Quality Management System you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.
This role is responsible for establishing policies and procedures that drives continuous improvement and regulatory compliance of Chapter 3 Facilities Production Process & Test Controls within Baxters global Quality Management System. Chapter 3 includes facilities design and control critical equipment and systems validation production controls and laboratory processes used for product release and submissions.
Your Team at Baxter
Within Quality every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether its building a new process from scratch or facing a neverbeforeseen production hurdle individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds we will always choose quality. Our patients come first always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves so does the way our team approaches work as it strives to create topoftheline products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable ethical and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when theres a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
What youll be doing
- Responsible for the lifecycle management of policies and procedures in the GxP Quality Management System (QMS) framework including enforcing QMS governance and providing support with document authoring approval and development of implementation strategies for the segments
- Provides direction and/or facilitates SME participation forums (Subject Matter Expert Councils/Communities of Practice/Governance) needed for the development and maintenance of compliant global QMS process documents
- Measures and reports quality system deployment effectiveness and drives continuous improvement initiatives based upon stakeholder feedback
- Guides and supports global information technology (IT) system implementations (i.e.: eQMS)
- Frequently interacts with all levels of the organization to collaborate on key initiatives needed to drive desired QMS outcomes
What youll bring
- Bachelors degree in science or engineering; advanced degree helpful
- 7 years experience working in Quality Manufacturing Engineering or related field
- 3 years experience working in manufacturing plant laboratory and/or technical service
- Knowledge and understanding of international regulations and standards
- Experience with regulatory agencies and/or notified bodies including explaining and defending process and policies
- Strong leadership skills capable of managing multiple priorities
- Strong interpersonal skills able to effectively communicate influence and negotiate a highly matrixed organization
- Strong project management and technical writing skills
- Must be able to travel if needed
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating inperson in support of our Mission.
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 $136000 $187000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses and/or longterm incentive. 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.
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Bachelors Degree 16 years)US Benefits at Baxter (except for Puerto Rico)
This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm 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 timeoff 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.
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.
Required Experience:
Senior Manager
Employment Type
Full-Time
