Quality Engineer delivering high quality software through mix of automated and manual testing. Collaborating with Scrum team to improve test automation frameworks and utilizing AI tools where beneficial.
About the role
- Director/Sr. Director, Quality Assurance responsible for GCP Quality and Compliance at BridgeBio Pharma. Leading audits and regulatory interactions, ensuring compliance with international guidelines.
Responsibilities
- Support internal and external GCP audit program
- Lead and/or participate in vendor and investigator site audits
- Review and/or approval of audit reports and CAPA responses
- Manage and/or assist with regulatory inspections and the development and tracking of regulatory commitments
- Communicate critical information regarding significant quality or patient safety risk to Executive Management and key stakeholders
- Partner cross-functionally to support the business with compliance issues/concerns by ensuring appropriate evaluation and mitigation
- Assist the organization with developing and continuously improving processes and systems
- Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to policies and practices as needed
Requirements
- Bachelor’s degree with 15+ years of relevant clinical Quality experience within a biopharmaceutical company
- Current knowledge of global GxP regulations
- Ability to engage in cross-functional interactions with internal and external staff
- Excellent verbal and written communications skills, with a strong customer focus
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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