Quality Assurance Manager, EU
March 18
Description
• Manage quality assurance lot release activities for the disposition of drug substance (DS), drug product (DP), and finished drug products manufactured by BridgeBioContract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs), and/or Contract Testing Laboratories (CTLs), referred to here as Suppliers. • 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 • 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 • Review process and method validation protocols and reports • Participate in the GMP vendor qualification and audit programs and monitor Supplier performance • Participate in hosting regulatory inspections • Participate in internal and external project team meetings • Write and review SOPs and quality assurance procedures
Requirements
• 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
Benefits
• 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
Apply Now