Associate Director, Clinical Audits

OverviewJoin to apply for the Associate Director, Clinical Audits role at Baxter International Inc.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Mission is to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration. Here, you will find purpose and pride.Your role at BaxterThe Associate Director Clinical Audits is responsible for leading the Clinical Audit Program, collaborating with clinical operations, suppliers/vendors, and Baxter’s functions/businesses. Grow clinical auditing capability, utilizing best-practice methodologies and practices in industry, and work closely with global quality compliance partners to ensure a robust Clinical Audit plan and strategy.What you'll be doingDevelop and maintain the annual risk-based Clinical Audit schedule following global Audit Program and external requirements.Lead the preparation of, conduct, and reporting of Clinical Audits including clinical investigator sites, clinical research organizations, and internal processes/systems. Present and report Audit results concisely and logically both verbally and in writing to senior global quality compliance leadership.Review Clinical Audit observation responses and ensure Corrective and Preventive Action (CAPA) plans adequately address observations, root causes, and effectiveness checks.Maintain responsibility for and oversight of Clinical Audits conducted by contractors, when applicable. Identify suitable Clinical Audit consultants, work with Procurement to establish contracts, and provide relevant training.Develop relationships with clinical research vendors’ quality leaders through audits and project teams; establish one-on-one relationships.Serve as Subject Matter Expert/Point of Contact to provide expertise to less experienced Auditors, business partners and company entities on clinical processes. Provide clinical compliance expertise including supporting the generation of clinical Audit metrics, creation and revision of SOPs.Participate in external inspections in core and supporting roles, assisting with the preparation and delivery of training materials, and advising auditee coaching.Identify potential issues and risks with impact on clinical trials or processes and ensure communication.What you'll bringA Bachelor's degree in life science or engineering; an advanced degree is preferred.Minimum 10 years’ experience in pharmaceutical and/or medical device industries, with 5 years as a Lead Auditor.2 years’ experience with Regulatory Inspections Management (e.g., MHRA, FDA, EU inspections)1–5 years program and people management experience in a matrix organization.Demonstrated leadership with strong communication and relationship-building skills.ASQ certification, IRCA or other relevant auditor certification is a plus.Advanced knowledge of clinical regulations and standards (FDA, ISO, ICH, EMA, MDR, IVDR, GDPR) with practical application of GCP requirements.Clinical Quality assurance experience in medical devices and/or pharmaceuticals; significant medical device experience in clinical research preferred.Understanding of clinical development programs, quality management systems, and quality control tools.Knowledge of Clinical Data Management and Biostatistics processes.Ability to collaborate with all leadership levels through written and verbal communication.Ability to travel up to 50% of the time and accommodate time zone differences for remote pensation and BenefitsThe estimated base salary for this position is $152,000 to $209,000 annually. The range reflects an anticipated salary but may vary based on market data, location, skills, experience, and other factors. This position may be eligible for discretionary bonuses.US Benefits at Baxter (except for Puerto Rico): Baxter offers comprehensive compensation and benefits packages, including medical and dental coverage from day one, life and disability insurance, ESPP, 401(k) with company matching, FSA, educational assistance, paid time off, holidays, and other benefits. For details, please speak with your recruiter or visit the Benefits site: Benefits | BaxterEqual Employment Opportunity and AccommodationsBaxter 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.Know Your Rights: Workplace Discrimination is IllegalReasonable Accommodations: Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for any part of the application or interview process, please click the link and let us know the nature of your request along with your contact information.Recruitment Fraud Notice: Baxter has discovered incidents of employment scams. To protect yourself, review our Recruitment Fraud Notice. #J-18808-Ljbffr

Created: 2025-09-17