Senior QA Técnico validating complex solutions for Stefanini focused on real - time data flows and APIs. Collaborating in Scrum methodology ensuring quality across teams in a hybrid work environment.
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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