SW QA Engineer responsible for testing multidisciplinary Embedded Systems. Involved in Agile processes at Harmonic, enhancing broadband solutions through quality assurance.
About the role
- Associate Director providing Clinical Quality Assurance expertise at BridgeBio Pharma. Leading quality management system development and compliance for clinical studies with high expectations for performance.
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
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
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
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