Associate Director, Clinical Quality Assurance

March 13

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Baxter International Inc.

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Baxter International Inc. is an innovative, global healthcare leader that offers advanced products, technologies, and therapies to support people in leading healthier, longer lives. The company is committed to meeting the challenges faced by patients, clinicians, and customers in the evolving healthcare landscape, emphasizing resilience and a mission to save and sustain lives.

Medical Devices • Biosurgery • Anesthetics • Pharmacy Automation

10,000+ employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Grant on 2021-04

📋 Description

• Lead activities to ensure clinical trial “Audit Ready”. • Manage Clinical Quality Assurance Program, vendor qualification and oversight. • Accountability for clinical trial policies, investigation of quality concerns and regulation compliance. • Develop and execute risk-based quality assurance strategies supporting clinical operations activities. • Maintain knowledge of FDA and other regulatory agencies’ activities, regulations and guidelines. • Provide expertise and guidance for government and agency guidelines to assure GCP compliance. • Independently support regulatory inspections of Sponsor, GCP sites and GCP vendors. • Support Quality Planning Process and clinical quality systems management.

🎯 Requirements

• Bachelor’s Degree required, preferably in the life sciences. • Minimum ten years’ experience working within a regulated bio-medical industry, verifying compliance to global regulations. • People management experience of 1+ years. • Clinical quality assurance, medical device and/or pharmaceutical experience, with significant medical device experience in clinical research highly preferred. • Certified auditor is a preference. • Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools. • Advanced knowledge of and experience with all regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR, GDPR). • Knowledge of and experience with OUS country related regulations. • Knowledge of processes related to Clinical Data Management and Biostatistics functions. • Experience partnering with Regulatory Affairs and/or Quality department. • ASQ certification, IRCA or other relevant auditor certification a plus. • Effective communication skills both verbal and written. • Ability to work independently with minimal supervision and accountable for managing multiple clinical quality study activities concurrently. • Demonstrates leadership abilities. • Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships. • Anticipates problems, issues, and delays; proactively looks to minimize the impact of identified compliance issues. • Multi-disciplinary knowledge across functional areas.

🏖️ Benefits

• Comprehensive compensation and benefits packages for eligible roles. • Medical and dental coverage that starts on day one. • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. • Employee Stock Purchase Plan (ESPP) to purchase company stock at a discount. • 401(k) Retirement Savings Plan with options for employee contributions and company matching. • Flexible Spending Accounts. • Educational assistance programs. • Paid holidays and paid time off ranging from 20 to 35 days based on length of service. • Paid parental leave and family medical leaves. • Commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits.