Senior Director of QC
Our client is seeking a Senior Director, Quality Control to provide strategic, technical, and operational leadership for QC-related activities. The Senior Director will oversee methods transfer, feasibility assessment, qualification/validation, as well as specification setting, support phase-appropriate critical quality attribute determination for all of the company's cell therapy assets.
- Plan a sustainable cGMP QC platform to support a growing portfolio of clinical development programs. This includes ensuring a harmonized approach to method development that supports the transition and implementation of methods fit for commercial QC support.
- Develop phase-appropriate QC capabilities, business processes, and procedures.
- Support internal and external cGMP manufacture and supply of high-quality cell therapy products for clinical trials, including oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.
- Oversee and manage method validation, transfer, testing
- Select and oversee contract QC laboratories including technical due diligence, routine performance management, and audits to ensure sustained quality analytical deliverables.
- Ensure that QC is aligned with all CMC stake holders
- Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function remains in compliance with applicable company requirements and global regulations.
Skills and Requirements:
- Advanced degree with at least 10 years of relevant experience.
- In-depth technical and regulatory understanding of biologics, gene, or cell therapy QC with an understanding of the control strategy for these drug classes
- Proven leadership experience and people management skills.
- Excellent written and verbal communication skills.
- Experience with regulatory submissions, ideally for products which were ultimately approved for commercial distribution, and regulatory inspections.
- Strong collaboration, team-building, and organizational skills are required; proven ability to effectively develop, communicate, and gain support for execution of plans and strategies with a wide range of stakeholders.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.
- Ability to work in a fast paced and dynamic environment that will require management of several competing priorities while driving all projects forward and meeting program/project deliverables.
If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or email@example.com.
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