Associate Director, Clinical Audits (Remote)

1-10 years

$152,000 – $209,000

Remote, USA

10 Oct. 30, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧾 Position Title: Associate Director, Clinical Audits (Remote)

Req ID: JR-177640
Location: United States (Remote)
Job Category: Quality / Clinical Compliance
Reports To: Senior Director, Global Quality Compliance
Travel Requirement: Up to 50% (includes remote audits across time zones)

🧭 Overview:

At Baxter, every team member contributes to our mission to save and sustain lives.
The Quality organization plays a vital role across the entire product lifecycle, ensuring the highest standards of patient safety and regulatory compliance.

This role provides an opportunity to make a global impact on clinical quality systems, collaborate across business units, and lead audit programs that directly support the integrity of Baxter’s clinical research and development.

🎯 Position Summary:

The Associate Director, Clinical Audits is responsible for leading Baxter’s Global Clinical Audit Program — ensuring robust governance, risk-based audit planning, and compliance with international clinical research regulations (FDA, EMA, ICH, ISO, MDR, IVDR, GDPR).

The role requires strategic oversight, leadership of clinical audits (internal and external), and partnership with vendors, CROs, and clinical operations to ensure the highest standards of Good Clinical Practice (GCP) compliance.

⚙️ Key Responsibilities:

1. Audit Program Leadership

Develop and maintain an annual risk-based Clinical Audit schedule in alignment with global Audit Program and regulatory requirements.
Lead the planning, execution, and reporting of Clinical Audits for:
- Clinical investigator sites
- Contract Research Organizations (CROs)
- Internal clinical systems and processes
Present audit outcomes to senior global quality leadership with concise, logical reports and recommendations.

2. CAPA & Compliance Oversight

Review and evaluate audit responses and CAPA plans, ensuring:
- Root causes are correctly identified
- Actions are effective and measurable
Track closure of audit findings and maintain strong follow-up processes.

3. Vendor & Contractor Management

Oversee external clinical auditors or consultants, including:
- Qualification and selection in partnership with Procurement
- Training and alignment with Baxter’s audit procedures
- Performance monitoring and deliverable review

4. Expert Support & Cross-functional Collaboration

Serve as Subject Matter Expert (SME) for Clinical Audit processes and GCP compliance.
Mentor and support junior auditors and business partners.
Develop and maintain audit metrics, dashboards, and SOP documentation.
Participate in regulatory inspections (FDA, MHRA, EMA) and support inspection readiness activities.

5. Risk Identification & Communication

Identify emerging risks or compliance gaps in clinical trial operations.
Collaborate with internal stakeholders to develop and implement mitigation plans.

🧠 Qualifications & Experience:

Education:

Bachelor’s degree in Life Sciences, Pharmacy, or Engineering (required)
Advanced degree (M.Sc., Pharm.D., or equivalent) preferred

Experience:

10+ years in the pharmaceutical and/or medical device industry
5+ years as a Lead Clinical Auditor
2+ years experience managing Regulatory Inspections (FDA, MHRA, EMA, etc.)
1–5 years of program and people management in a matrix environment

Technical Expertise:

Deep knowledge of GCP, ISO 14155, ICH-GCP, FDA, EMA, MDR/IVDR, and GDPR.
Hands-on experience in Clinical Quality Assurance (CQA) within medical device and pharmaceutical settings.
Understanding of Clinical Development, Clinical Data Management, and Biostatistics processes.
Proficiency with Quality Management Systems (QMS) and audit tools.

Certifications (Preferred):

ASQ Certified Quality Auditor (CQA) or IRCA Certification

💬 Soft Skills:

Strong leadership and relationship-building abilities
Excellent communication and presentation skills (verbal & written)
Analytical thinking, attention to detail, and organizational excellence
Ability to collaborate across diverse, global teams

💰 Compensation:

Estimated Base Salary: $152,000 – $209,000 (USD) annually
Additional: Eligible for discretionary performance bonus

Final pay determined by experience, skills, and market factors.

🌟 U.S. Benefits (Except Puerto Rico):

Health & Well-being: Medical, Dental, and Vision coverage from Day One
Insurance: Life, Accident, Short-term and Long-term Disability
Financial Benefits:
- 401(k) Retirement Savings Plan with Company Match
- Employee Stock Purchase Plan (ESPP)
- Flexible Spending Accounts (FSA)
Work-life Balance:
- Paid Time Off (20–35 days based on tenure)
- Paid Holidays
- Paid Parental Leave
- Family & Medical Leave
- 2 Days per Year for Volunteering
Additional Perks:
- Educational Assistance & Professional Development
- Commuting & Childcare Benefits
- Employee Assistance & Discount Programs

⚖️ Equal Employment Opportunity:

Baxter is an Equal Opportunity Employer.
All qualified applicants are considered without regard to race, color, religion, gender, sexual orientation, age, disability, or veteran status.

📜 Reference:
[Know Your Rights: Workplace Discrimination is Illegal]

♿ Reasonable Accommodation:

Applicants needing accommodations due to disability or medical condition can submit a request through Baxter’s Reasonable Accommodation Portal.

⚠️ Recruitment Fraud Notice:

Baxter never requests payment, banking, or personal financial information during recruitment.
Refer to the Baxter Recruitment Fraud Notice for official verification steps.

📍 Work Mode:

Remote (U.S.) — Travel up to 50% for audits and global collaboration

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Associate Director, Clinical Audits (Remote)

Job Description

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