Associate Director, Clinical Quality Assurance
About The Position
The Associate Director, Clinical Quality Assurance provides expert guidance on Good Clinical Practice (GCP) compliance and quality oversight for clinical studies. This role supports the development and maintenance of the Quality Management System, ensures proper documentation and resolution of quality events, and leads process improvement initiatives. Responsibilities include reviewing clinical trial documents, planning and/or conducting internal and external audits, and supporting regulatory inspections. The position is critical for driving continuous improvement and maintaining adherence to industry standards and regulatory requirements.
Requirements
- Bachelor's degree in a scientific discipline or equivalent experience
- Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
- Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
- Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
- Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
- Attention to detail and proper use of tools for information processing and electronic quality management systems
Responsibilities
- Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
- Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
- Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
- Lead small-scale process improvement projects, as needed
- Provide clinical quality assurance SME review of clinical protocols, and other clinical trial-related documents
- Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
- Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
- Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.
- Other duties as assigned or required
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
- People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
- We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
501-1,000 employees
