Senior Manager / Manager, Quality Assurance Compliance

Job Description

• Managing global Quality Agreements with external stakeholders.
• Collaborating with internal cross-functional teams and external stakeholders.
• Coordinating regulatory authority inspection readiness activities.
• Participating in the global supply chain vendor qualification process.
• Participating in the planning and conduct of internal and external audits.
• Ensuring audit findings are followed up and corrective actions are implemented.
• Identifying and assessing risks to compliance and developing mitigation strategies.
• Supporting the development of quality metric reports or dashboards.
• Participating in hosting regulatory inspections.
• Assisting in the creation and revision of applicable procedures.
• Staying informed of relevant regulations and standards.

• Bachelor’s degree in science, mathematics, or engineering.
• 8 years of experience in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field.
• Working knowledge of cGMPs and applicable international regulations/guidance.
• Experience reviewing audit reports, quality agreements, and procedures.
• Prior experience with a commercial product.
• Prior experience in supporting PAI and regulatory inspection readiness.
• Strong planning and time management skills.
• Excellent analytical and problem-solving skills.
• Proficiency in document and presentation office tools.
• Basic understanding of data concepts and ERP systems.
• Eligible to work in The Netherlands.

• Patient Days to hear directly from individuals living with the conditions they are seeking to impact.
• A collaborative, fast-paced, data-driven environment.
• Access to learning and development resources.
• Robust and market-competitive compensation & benefits package.
• Commitment to Diversity, Equity & Inclusion.