Associate Director, Clinical Audits
Baxter International Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $152,000 - $209,000 per year
Job Level
Senior
About the role
- Responsible for leading the Clinical Audit Program, collaborating with clinical operations, suppliers/vendors, and Baxter’s functions/businesses.
- 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.
- 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.
Requirements
- A degree in life science or engineering discipline is required; an advanced degree is preferred.
- 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.
- 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).
- 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.
Benefits
- Health insurance coverage starting on day one
- Dental coverage
- Basic life insurance
- Accident insurance
- Short-term and long-term disability insurance
- Business travel accident insurance
- Employee Stock Purchase Plan (ESPP) for discounted company stock purchase
- 401(k) Retirement Savings Plan with employee contributions and company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays and time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical AuditRegulatory Inspections ManagementClinical Quality AssuranceClinical Development ProgramsClinical Trial ProcessesQuality Management SystemsQuality Control ToolsClinical Data ManagementBiostatistics
Soft skills
LeadershipCollaborationCommunicationRelationship DevelopmentProblem IdentificationCoaching
Certifications
ASQ CertificationIRCA Certification