Quality Assurance Lead

As the Quality Assurance Lead, you will assume responsibility for supporting activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene therapy, extracellular vesicles, and using next generation manufacturing methods.

Sartorius is one of the world‘s leading technology providers to the life sciences and biopharma industries, and is actively shaping dynamic, innovative and high-growth markets. To drive the creation of new innovative solutions, Sartorius has formed an initiative to discover new trends and cutting-edge opportunities for rapid conversion towards next generation technology solutions. This exciting initiative enables the research, development and clinical production of novel modalities using next generation manufacturing platforms, in partnership with key customers.

As the Quality Assurance Lead, you must possess a strong background in Quality Systems, Document Control, Supplier Quality, and Validation within the biotech industry. This business-critical function will support the continuity of the quality systems across the process development and clinical manufacturing. 

What you will accomplish together with us:

Quality Systems Management:

• This role involves close collaboration with research and development, manufacturing, and regulatory teams to uphold and enhance quality standards.
• You will lead the implementation and maintenance of the Quality Management System (QMS) tailored to the biotechnology industry, ensuring compliance with regulatory standards such as FDA, EMA, and ICH guidelines.
• One of your tasks will be to drive continuous improvement initiatives within the QMS, including CAPA, change control, and risk management processes.
• You will ensure that all quality-related documentation is maintained in accordance with industry best practices and regulatory requirements.

Document Control:

• You will oversee the Document Control function to ensure that all critical documents, such as SOPs, batch records, and quality manuals, are controlled, accessible, and properly maintained.
• You will manage the lifecycle of documents, including creation, review, approval, distribution, and archiving, while ensuring version control and traceability.
• On an as needed basis, you will conduct periodic reviews and audits of the Document Control System to verify compliance and identify areas for improvement.

Supplier Quality:

• In this role, you will develop and manage a robust Supplier Quality program, including the assessment and qualification of suppliers, vendors, and contract manufacturers.
• One of your duties will be to collaborate with suppliers to ensure the quality of raw materials, components, and services used in biotechnological processes.
• You will perform supplier audits and assessments, and work with suppliers to address non-conformances and drive quality improvements.

Validation:

• Lead the development and execution of validation strategies for biotechnological processes, equipment, and cleaning procedures, ensuring adherence to industry-specific validation requirements.
• Oversee the preparation and execution of validation protocols (IQ, OQ, PQ) and ensure proper documentation of validation activities.
• Review and approve validation reports, ensuring that all validation activities are conducted in accordance with regulatory expectations and scientific principles.

Quality Assurance Leadership:

• Provide leadership and guidance to the QA team, fostering a culture of quality and compliance.
• Develop team members through training, mentoring, and performance management.
• Facilitate cross-functional collaboration to proactively address quality issues and support the development and commercialization of biotechnological products.

Regulatory Compliance:

• Maintain up-to-date knowledge of regulatory requirements specific to the biotechnology industry and ensure company-wide compliance.
• Lead preparation efforts for regulatory inspections and audits and manage responses to findings.
• Ensure that all quality-related activities are conducted in accordance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and other relevant standards.

Quality Metrics and Reporting:

• Establish and track key quality metrics to monitor the effectiveness of the quality system and identify areas for improvement.
• Generate and present quality reports to senior management, providing insights into quality trends, compliance risk