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. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s 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

The 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 DOING

• Develop 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 procedures.
• Interacts 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.