Associate Director, Clinical Audits

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.

What you'll bring

• A 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 audits.

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 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 antic