Senior Regulatory Affairs Specialist Jobs

Oversee and ensure quality compliance for federal HVAC and electrical upgrade projects, managing inspections and adherence to GSA standards while collaborating closely with contractors and government...

Take ownership of validating automated systems within GMP environments, ensuring compliance with FDA standards and driving operational excellence through collaboration with cross-functional teams in m...

Architect global compliance strategies for Direct Materials Certification. Lead modernization, streamline processes across Biologics and Molecules, and resolve complex regulatory challenges while ensu...

Architect enterprise-level Direct Materials Certification strategies, ensuring compliance and driving modernization. Influence stakeholders to solve regulatory challenges and enhance supply chain flex...

Champion regulatory excellence by leading submissions and ensuring compliance with FDA guidelines while collaborating with cross-functional teams to support innovative biopharmaceutical products...

Join a team that's implementing advanced Manufacturing Execution Systems to support cutting-edge drug product manufacturing. Engage in greenfield project execution, ensuring operational excellence and...

Grow your career with a pivotal role that enhances clinical integration and product adoption through collaboration, education, and evidence-based insights to elevate patient care experiences across he...

Lead commissioning, qualification, and validation efforts for GMP facilities and systems in cell therapy manufacturing, ensuring compliance and implementing risk-based strategies aligned with industry...

Lead and enhance commissioning, qualification, and validation processes for GMP cell therapy manufacturing, ensuring compliance and best practices are met while driving proactive issue resolution and...

Deliver key leadership in CQV activities for GMP cell therapy manufacturing, ensuring compliance with best practices and regulatory standards. Lead qualification strategy, execution, and oversight acr...

Drive and own CQV activities, ensuring compliant, risk-based validation for GMP cell therapy manufacturing, equipment, and computerized systems, enhancing quality and efficiency in a fast-paced enviro...

Join a dynamic team to design and conduct experiments in immunology, focusing on innovative approaches and solving complex biological challenges. Engage with key stakeholders while managing project mi...

Manage supplier quality processes ensuring compliance with regulatory standards, customer requirements, and effective QA/QC principles. This role involves oversight of audits, inspections, and cross-f...

Lead the charge in ensuring compliance of drug substances with FDA and international standards. Engage with cross-functional teams and support audits while managing GMP documentation to drive continuo...

Lead automation engineering initiatives to enhance sterile clinical manufacturing processes. Ensure cGMP compliance and reliability of automation systems, driving continuous improvement and supporting...

Drive innovation and success by serving as the Subject Matter Expert for electronic engineering systems. Collaborate with internal and external stakeholders to optimize system interoperability and lea...

Tackle quality engineering initiatives for IVD products, ensuring compliance and excellence. Lead risk management, validation processes, and continuous improvement efforts while mentoring teams in ach...

Join a team that's driving innovation in chromatography products, shaping strategies, and expanding market reach. Collaborate across global teams, provide technical expertise, and deliver exceptional...

Seeking a Senior Quality Engineer to enhance quality systems, oversee projects, and lead audits, ensuring compliance and improvement of processes. Collaborate across departments to assure product qual...

Drive innovative engineering solutions for complex cardiovascular projects, leveraging comprehensive technical knowledge and expertise. Ensure quality and compliance in product design, analysis, and d...

Develop innovative test methodologies and execute validation plans for medical devices. Lead verification efforts, conduct failure investigations, and collaborate on cross-functional projects to impro...

Accelerate progress at vendor management by overseeing approvals and evaluations. Act as a subject matter expert for the vendor evaluation process, ensuring quality and compliance through audits and t...

Transform quality assurance processes by ensuring compliance with FDA, EU, and ISO standards. Collaborate on audits, document control, and continuous improvement projects to enhance the effectiveness...

Engage in strategic planning and control for BioPharma Manufacturing. Collaborate across functions and regions, oversee project governance, track KPIs, and drive initiatives to ensure operational effi...

Lead the charge in ensuring quality compliance through effective NC/CAPA investigations. Support and coach teams in root cause analysis, escalate issues as necessary, and maintain regulatory standards...