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The Senior Specialist will ensure compliance with 21 CFR Part 11 and Data Integrity for GMP computerized systems during design and lifecycle management in a new monoclonal antibody drug manufacturing facility. This role involves leadership in quality systems, operational readiness, data integrity compliance, and collaboration with cross-functional teams during facility start-up and tech transfer activities.

The Specialist II, Quality Systems and Compliance ensures compliance with regulations for GxP computerized systems during design and lifecycle management. Responsibilities include implementing Quality Systems, collaborating cross-functionally, and ensuring adherence to Data Integrity and risk management procedures. The role is involved in operational readiness and inspection management within manufacturing for Phase III and early commercial products.

The Senior Specialist in Quality Assurance will lead activities related to the Quality Assurance organization in a new monoclonal antibody drug substance manufacturing facility. Responsibilities include ensuring compliance with GxP standards, establishing quality procedures, coordinating site activities, mentoring QA employees, and overseeing validation and qualification processes.

The Senior Research Scientist in Cell and Gene Therapy will lead pharmacologic evaluations, conduct in vivo studies, manage project timelines, and oversee team training. The role also involves preparing regulatory documentation and managing project budgets while contributing to research strategies in cell and gene therapy.

The Manager of Patient Services Training and Development designs and facilitates training solutions for the Patient Services department, collaborating with key stakeholders to address knowledge gaps and enhance employee performance. They manage vendor relationships, develop training materials, and report on program effectiveness.

The Employee Relations Specialist will support HR business partners by managing employee inquiries, conducting investigations into complaints, implementing HR policies and procedures, and promoting a positive workplace culture. They will assist with talent management and provide recommendations on performance issues, while ensuring compliance with labor laws.

As a Quality Assurance Intern, you will assist the Quality Assurance team with tasks related to pre-approval inspections (PAI), including document preparation, migration tasks, and collaboration with various departments to ensure document accuracy and availability. This position provides a broad understanding of the pharmaceutical industry and cGMPs.