Baxter International Inc.
Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device
Baxter International Inc., Deerfield, Illinois, United States, 60063
Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)
Join to apply for the
Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)
role at
Baxter International Inc. Overview
This role leads clinical quality assurance efforts across Baxter, focusing on proactive regulatory changes, compliance with industry best practices, and process improvements in clinical trials for pharmaceuticals and medical devices. A strong understanding of clinical regulations, quality management systems, and industry trends is required. What You’ll Be Doing
Independently lead the development and implementation of clinical quality assurance strategies to ensure regulatory compliance. Proactively anticipate regulatory changes and ensure current GCP/Clinical Trial practices reflect current and future industry practice. Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO. Offer subject matter expertise to 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. Plan and monitor quality activities for Clinical Trials, including all phases 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 Baxter-sponsored human clinical research. Assess impact of Field Actions on ongoing or planned clinical trials. 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. Assist in collecting quality metrics for adequate study oversight. Identify and assess regulatory and quality risks in activities and processes as necessary. Drive process improvements and initiatives in support of continuous quality improvement. Maintain current and leading-edge expertise in quality management systems and 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 & Location
Reporting directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory, you will collaborate with cross-functional teams to ensure high-quality clinical data and reports. The role is located at Baxter’s global corporate headquarters in the greater Chicago, IL area (Deerfield). Flexible workplace policy applies, with a minimum onsite requirement; remote candidates within the US may also be considered. What You’ll Bring
Bachelor’s degree in a life science or related field is required. Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or related field. Experience in managing clinical quality assurance teams and developing quality management systems. Experience in Clinical Trials, Phase 0 – IV; Pharmaceuticals and Medical Device Clinical Trials. Experience performing laboratory, GCP, GMP audits is 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. Compensation & Benefits
The estimated base salary range for this position is $136,000 – $187,000 annually. Actual pay may vary based on location, skills, experience, and market conditions. Eligible for discretionary bonuses and/or long-term incentive. Benefits include medical and dental coverage from day one, life and disability insurance, 401(k) with company matching, ESPP, FSA programs, paid holidays, PTO, family and medical leaves, paid parental leave, and more. Specific benefits vary by location. Equal Employment Opportunity & Accommodations
Baxter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability, or any other legally protected characteristic. Reasonable accommodations are provided for applicants with disabilities upon request. For details, refer to the Recruitment Fraud Notice and our Benefits information. Legal Notices
Know Your Rights: Workplace Discrimination is Illegal. Baxter’s Recruitment Fraud Notice is provided for awareness.
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Join to apply for the
Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)
role at
Baxter International Inc. Overview
This role leads clinical quality assurance efforts across Baxter, focusing on proactive regulatory changes, compliance with industry best practices, and process improvements in clinical trials for pharmaceuticals and medical devices. A strong understanding of clinical regulations, quality management systems, and industry trends is required. What You’ll Be Doing
Independently lead the development and implementation of clinical quality assurance strategies to ensure regulatory compliance. Proactively anticipate regulatory changes and ensure current GCP/Clinical Trial practices reflect current and future industry practice. Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO. Offer subject matter expertise to 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. Plan and monitor quality activities for Clinical Trials, including all phases 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 Baxter-sponsored human clinical research. Assess impact of Field Actions on ongoing or planned clinical trials. 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. Assist in collecting quality metrics for adequate study oversight. Identify and assess regulatory and quality risks in activities and processes as necessary. Drive process improvements and initiatives in support of continuous quality improvement. Maintain current and leading-edge expertise in quality management systems and 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 & Location
Reporting directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory, you will collaborate with cross-functional teams to ensure high-quality clinical data and reports. The role is located at Baxter’s global corporate headquarters in the greater Chicago, IL area (Deerfield). Flexible workplace policy applies, with a minimum onsite requirement; remote candidates within the US may also be considered. What You’ll Bring
Bachelor’s degree in a life science or related field is required. Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or related field. Experience in managing clinical quality assurance teams and developing quality management systems. Experience in Clinical Trials, Phase 0 – IV; Pharmaceuticals and Medical Device Clinical Trials. Experience performing laboratory, GCP, GMP audits is 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. Compensation & Benefits
The estimated base salary range for this position is $136,000 – $187,000 annually. Actual pay may vary based on location, skills, experience, and market conditions. Eligible for discretionary bonuses and/or long-term incentive. Benefits include medical and dental coverage from day one, life and disability insurance, 401(k) with company matching, ESPP, FSA programs, paid holidays, PTO, family and medical leaves, paid parental leave, and more. Specific benefits vary by location. Equal Employment Opportunity & Accommodations
Baxter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability, or any other legally protected characteristic. Reasonable accommodations are provided for applicants with disabilities upon request. For details, refer to the Recruitment Fraud Notice and our Benefits information. Legal Notices
Know Your Rights: Workplace Discrimination is Illegal. Baxter’s Recruitment Fraud Notice is provided for awareness.
#J-18808-Ljbffr