Quality Assurance Manager, EU
BridgeBio
- Nederland
- Vast
- Voltijds
- Provide oversight and quality support of third-party manufacturing sites, including drug substance, drug product, analytical, packaging, and labeling sites, primarily located in the EU and UK
- Perform quality review and guide quality events (deviations, change requests, supplier notifications, etc.) as documented by Suppliers and manufacturing operations departments
- Develop quality assurance capabilities to support new product introductions
- Represent QA on project teams for assigned Suppliers
- Review master and manufacturing batch records from Suppliers, including related documents such as specifications, analytical and microbiological methods, stability study protocols, and label proofs
- Manage lot release activities and communication of lot release schedules to key stakeholders
- Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
- Participate in the GMP vendor qualification and audit programs and monitor Supplier performance
- Review process and method validation protocols and reports
- Review analytical test results to ensure compliance with approved specifications
- Assist in updating CMC sections of regulatory and quality documents
- Participate in hosting regulatory inspections
- Participate in internal and external project team meetings
- Write and review SOPs and quality assurance procedures
- Position could have a responsibility to manage subordinates in the future
- Other duties as assigned
- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
- Bachelor's degree or equivalent in operations, science, mathematics, or engineering required
- Extensive knowledge of US and European drug substance and drug product GMP requirements and associated guidelines
- Must have previous experience with managing international pharmaceutical CMOs/CPOs/CTLs
- Experience in the identification and resolution of GMP quality and compliance issues
- Strong understanding of supply chain concepts, supplier management, and inventory management
- Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers
- Vital planning and time management skills with the ability to prioritize workload
- Excellent analytical and problem-solving skills, with keen attention to detail
- Proficiency in document and presentation office tools (Microsoft Office, Google Docs, etc.)
- Basic understanding of data concepts and enterprise resource planning (ERP) systems
- Previous experience managing subordinates
- Ready to embrace companies core values and diverse corporate culture
- Minimum ten years of experience (or eight years with a Master's Degree) in a quality assurance role in the pharmaceutical industry required
- Travel estimate: 15% of the time
- Eligible to work in The Netherlands
- Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
- A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
- A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs
- Commitment to Diversity, Equity & Inclusion