Assoc Dir, Clinical Audits at Baxter International

Deerfield, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

A degree in life science or engineering discipline (advanced degree 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

Responsibilities

Lead 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
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, including identifying suitable Clinical Audit consultants, working with Procurement to establish contracts, and providing relevant training in accordance with company procedures
Interact and develop relationships with clinical research vendors’ quality leaders through audits, project teams, and establish one-on-one relationships
Serve as 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

Skills

Clinical Auditing

Risk-Based Auditing

Audit Scheduling

CAPA Management

Root Cause Analysis

Effectiveness Checks

Quality Compliance

Vendor Oversight

GCP

Audit Reporting

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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