Manager/Senior Manager, Quality Assurance Operations

Summary

Join BridgeBio Affiliate (Eidos Therapeutics) as a Manager/Senior QA Operations Manager and play a pivotal role in the batch release activities of drug substance (DS) and drug product (DP). You will oversee commercial contract manufacturing organizations (CMOs), ensuring compliance with regulations. This Netherlands-based remote role demands strong analytical and critical thinking skills for reviewing complex batch-related issues. Collaborate with internal and external stakeholders, manage batch release communications, and review crucial documents. Contribute to quality events management, communicate manufacturing deficiencies, and represent QA in project teams. The position requires a Bachelor’s degree, 8+ years of relevant experience in a regulated industry, and familiarity with cGMPs. The company offers market-leading compensation, a hybrid work model, and various skill development opportunities.

Requirements

• Bachelor’s degree or equivalent in science, mathematics, or engineering
• A minimum of 8 years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
• Working knowledge of cGMPs (CFR/ICH/EMA) and applicable international regulations/ guidance
• Prior experience with a commercial product
• Prior quality control/analytical development experience
• Excellent analytical, critical-thinking, and problem-solving skills, with keen attention to detail
• Ability to engage in cross-functional interactions with internal and external staff
• Strong planning and time management skills with the ability to prioritize workload
• Proficiency in document and presentation office tools (Microsoft Office, Excel, etc.)
• Basic understanding of data concepts and enterprise resource planning (ERP) systems
• Ready to embrace companies’ core values and diverse corporate culture
• Travel - 15% of time, domestic or international
• Eligible to work in The Netherlands

Responsibilities

• Manage batch release activities and communication of batch release schedules to key stakeholders
• Review and approve drug substance, drug product master, and manufacturing batch records and certificate of analysis from CMOs, including related documents such as specifications, analytical method transfer/method validation documents, and stability study protocols
• Perform quality review and guide quality events (deviations, OOSs/OOTs, change requests, supplier notifications, etc.) as documented by contract manufacturers and manufacturing operations departments
• Communicate manufacturing deficiencies/non-conformances to management and work with vendors to ensure timely resolution
• Represent QA on project teams responsible for drug substance and drug product manufacturing and testing
• Participate in the GMP vendor qualification, vendor audit, partner audit, and regulatory inspections as needed
• Monitor CMO performance
• Review process and method validation protocols and reports
• Review analytical test results to ensure compliance with approved specifications
• Participates as QA person-in-plant, internal, and external meetings
• Write and review SOPs and quality assurance procedures
• Other duties as assigned

Preferred Qualifications

• Preferably a QP or working experience with QP for batch release activities
• Prefer experience in oversight of external vendors
• Comfortable working in a virtual bio-pharmaceutical organization with multiple global third-party providers

Benefits

• Market leading compensation
• Referral program with $2,500 award for hired referrals
• Hybrid work model - employees have the autonomy in where and how they do their work
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities