Associate Director, Clinical Audits

This is whereyour work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—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 expertise, knowledge and experience of best-practice methodologies and practices in industry, working closely with global quality compliance partners to ensure a robust Clinical Audit plan and strategy is in place.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. This includes identifying suitable Clinical Audit consultants, working with Procurement to establish contracts and providing relevant training in accordance with company teracts and develops relationships with clinical research vendors/' quality leaders through audits, project teams, and establish one-on-one relationships.Subject Matter Expert/Point of Contact to provide expertise and knowledge 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 appropriate training materials, advising and contributing to auditee coaching.Identify potential issues and risks with impact on clinical trials or processes and ensure communication.What you/'ll bringA Bachelors/' degree in life science or engineering discipline is required; an advanced degree is preferred.Minimum 10 years/' experience working in pharmaceutical and/or medical device industries, with 5 of these 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, working in a matrix organization.Demonstrated ability to work as a leader with strong communication and relationship building skills.ASQ certification, IRCA or other relevant auditor certification a plus.Advanced knowledge of and experience with clinical regulations, and relevant standards (e.g., FDA, ISO, ICH, EMA, MDR, IVDR GDPR) with practical application and execution of GCP requirements.Clinical Quality assurance medical device and/or pharmaceutical experience, with significant medical device experience in clinical research highly preferred.Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools.Knowledge of processes related to Clinical Data Management and Biostatistics functions.Ability to collaborate and engage with all leadership levels through written and verbal communication.Ability to travel up to 50% of the time and accommodate time zone differences in case of remote pensation and BenefitsWe 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 $152,000 to $209,000 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 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.EligibilityApplicants 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.Equal Employment OpportunityBaxter 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.Reasonable AccommodationsBaxter 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 NoticeBaxter 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. #J-18808-Ljbffr

Created: 2025-09-17