Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)

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 at Baxter:

As a skilled Senior Manager Clinical Quality Assurance you will lead our clinical quality assurance efforts across Baxter. You will be responsible for proactively anticipating regulatory changes ensuring compliance with industry best practices and driving process improvements in clinical trials for all products pharmaceuticals and medical devices. Youll bring a strong understanding of clinical regulations quality management systems and industry trends.

What Youll Be Doing:

Clinical Quality Assurance Leadership:

• Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements

• Proactively anticipate the horizon of regulations and ensure that current GCP/Clinical Trial practices reflect current and future industry practice

• Provide clinical quality leadership expertise and support to Clinical Operations and the CMSO

• Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape

• Review and approve GQPs involving Human Subjects Research and Human Clinical Research

Quality Assurance Activities:

• Plan and monitor quality activities for Clinical Trials including all phases of clinical trials and post-market clinical studies

• Conduct sponsor clinical sites and vendor assessments as required

• Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations

• Handle clinical escalations non-conformances or CAPAs related to Clinical Trial operations and/or Clinical vendors

• Manage New Supplier Request process for Clinical vendors

• Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter

• Assess impact of Field Actions on ongoing or planned clinical trials

Regulatory Compliance:

• Interpret clinical regulations and provide guidance to Clinical Operations

• Ensure compliance with regulatory requirements including GCP FDA & EMEA regulations and other relevant standards

• Serve as an interface for inspections audits and inspections relating to GCP compliance

Quality Metrics and Risk Management:

• Assist in collecting quality metrics for adequate study oversight

• Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices

Process Improvements and Initiatives:

• Drive process improvements and initiatives in support of continuous process improvements

• Maintain current and leading-edge expertise in quality management systems and quality techniques

• Stay up-to-date with related quality legislation and compliance around clinical trials

• Travel to regulatory agencies industry conferences and other external meetings as required (not expected to exceed 25%)

Your Team:

As the Senior Manager Clinical Quality Assurance you will report directly to the Associate Director Clinical Operations Operations & Governance Worldwide Medical & Regulatory and work collaboratively with cross-functional teams to ensure the delivery of high-quality clinical data and reports.

Your Location:

The role is located at our global corporate headquarters in the greater Chicago IL area northern suburb of Deerfield. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion Baxter may decide to adjust suspend or discontinue as business needs change. Alternatively candidates residing anywhere in the US will also be considered.

What Youll Bring:

Bachelors degree in a life science or related field is required

Minimum 5-7 years of experience in clinical quality assurance regulatory affairs or a related field

Experience in managing clinical quality assurance teams and developing quality management systems

Experience in Clinical Trials Phase 0 IV.

Experience in Pharmaceutical and Medical Device Clinical Trials

Experience performing laboratory GCP GMP audits a plus.

Strong knowledge of clinical regulations quality management systems and industry trends

Ability to work independently and drive clinical quality assurance strategy and plans

Experience with clinical data management systems and processes

Strong leadership and communication skills

Ability to analyze and interpret complex data

Experience with quality management systems and auditing

#LI-JR1

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 our 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 the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term 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.

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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