Associate Director, Clinical Quality Assurance, Baxter

Baxter

Location:

United States

Category:

Research and Development

Contract Type:

Employment contract

Salary:

152000.00 - 209000.00 USD / Year

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Job Description:

The AD, Clinical Quality Assurance (CQA) is responsible for leading activities that result in being an organization that is clinical trial 'Audit Ready'. Key responsibilities include leading the Clinical Quality Assurance Program, vendor qualification and management activities, interpreting and applying current regulations, and ensuring compliance throughout clinical trials. The role requires extensive experience in quality assurance within regulated industries, managerial skills, and knowledge of global standards and regulations.

Job Responsibility:

Develops and executes risk-based quality assurance strategies to support clinical operations activities, which include assessment / audit planning, conduct, documentation and follow up of planned activities
Maintains knowledge of FDA and other regulatory agencies’ (e.g., European agencies) activities, regulations and guidelines relevant to Clinical Affairs
Monitors relevant agency compliance rulings and communications
Provides expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GCP compliance
Leads the supplier/vendor qualification and compliance oversight process related to Clinical research
In partnership with Quality, leads the development, implementation, and execution of GCP compliance auditing programs to ensure the fulfillment of regulatory requirements
Reviews and monitors Clinical research related Corrective Action/ Prevention Action Plans identified internally and/or externally and assist in root cause analysis and formulating responses
Independently supports regulatory inspections of Sponsor, GCP sites and GCP vendors
Supports the Quality Planning Process and risk profiling activity & mitigation approaches during clinical study life-cycle
Supports the management of clinical quality systems & continuous improvement
Interacts and develops relationships with clinical research vendors’ quality leaders through audits, project teams, and established one-on-one relationships
Writes GxP Quality SOPs in support of the Clinical Quality Systems
Ensures compliance with corporate policies and procedures as well as US or other applicable healthcare authorities’ laws and regulations through ongoing assessments during the conduct of clinical studies
Identifies additional capacity needs for clinical research audit activity, assist in sourcing, and train incumbents on internal SOP’s related to the clinical trial audit program
Development and maintenance of written internal procedures for clinical assessments and associated templates
Leads the production of training material and training sessions regarding compliance to clinical research policies, procedures, standards and regulations
Participation in external committees (e.g., AdvaMed) as requested
Manage a team of 1-4 employees who are responsible for supporting the clinical quality assurance program

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
Up to 20% travel
Remote

Nice to have:

Certified auditor is a preference
ASQ certification, IRCA or other relevant auditor certification a plus

What we offer:

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Comprehensive compensation and benefits packages including medical and dental coverage starting 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)
401(k) Retirement Savings Plan with employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid 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

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Associate Director, Clinical Quality Assurance