Director, Quality Practice Operations

Remote within U.S. Option Available
This is an exciting opportunity for an experienced life science manager to help grow, develop and build out a team of quality consultants, while also supporting internal employee development initiatives, consulting projects, business development, resourcing and client engagements. In this role, you will:

Consultant, Technology Solutions

Remote within U.S. Option Available
As a Consultant, Technology Solutions you will provide subject matter expertise to support a variety of client engagements focused in the area of life science technology enablement, leveraging your understanding of software used to support clinical trials and your strong computer validation skills.

Consultant, GMP Quality

Remote within U.S. Option Available
As a Consultant, GMP Quality, you will be responsible for providing quality assurance expertise to clients in the pharmaceutical and biotech industries. Responsibilities include establishing project timelines, quality and resource objectives, managing Good Manufacturing Practices (GMP) activities, and providing other quality activities including Gap Analysis, Inspection Readiness, Process Improvement, and Corrective and Preventative Action (CAPA) review.

Consultant, GCP Quality

Remote within U.S. Option Available
As a Consultant, Quality, you will be responsible for providing clinical quality assurance expertise to clients in the pharmaceutical and biotech industries. Responsibilities include establishing project timelines, quality and resource objectives, managing Good Clinical Practices (GCP) activities, and providing other quality activities including Gap Analysis, Inspection Readiness, Process Improvement, and Corrective and Preventative Action (CAPA) review.

Senior Consultant, Regulatory CMC (Small Molecules)

Remote within U.S. Option Available
As a Senior Consultant, Regulatory CMC, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, independently developing regulatory strategies, and leading the preparation, authoring, and review of regulatory submissions. Additionally, you will take a leadership role in interacting with the FDA, interact with potential clients in a business development role, and ensure consistent high-quality delivery of client deliverables and goals.

Principal Consultant, GxP Quality

Remote within U.S. Option Available
As a Principal Consultant, GxP Quality, you will provide leadership, strategic vision and support to the development quality consulting business to ensure successful engagement, scoping, execution and delivery of client work. Additional responsibilities include providing creative and strategic quality and compliance approaches to meet the unique needs of each client, acting as head of quality for the development-stage business, and leading and managing quality team members.

Senior Consultant, GCP Quality

Remote within U.S. Option Available
As a Senior Consultant, Quality, you will be responsible for providing clinical quality assurance expertise to clients in pharmaceutical and biotech industries. This role will require you to utilize your background and expertise in GCP quality management to drive our firm’s strategic quality business and provide consulting expertise to clients.

Associate Principal Consultant, Organizational Solutions

Remote within U.S. Option Available
As an Associate Principal Consultant, Organizational Solutions you will act as a subject matter expert and direct client engagements and contribute to staff development (as applicable). You will work with a variety of senior level stakeholders to plan, develop, and deliver consulting services in the areas of life science organizational excellence. We enable our clients and their teams to ensure they are equipped and empowered to act quickly and strategically while embracing the change. We transform strategies and operational plans across company infrastructure: people, process, data and technology. You should have an advanced understanding of the life sciences’ product development functions (clinical operations, data management/biometrics, regulatory, medical affairs, etc.), continuous improvement, process and performance metrics, and change management and a proven track record in building and managing durable partner and customer relationships.
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