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Senior Director of IDMO Site Quality

CellaresBridgewater, NJ
On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

Qualifications:Proven leadership experience in a cGMP manufacturing environment. Strong understanding of Quality Management Systems (QMS) and regulatory compliance. Ability to collaborate effectively across multiple disciplines and functions. Excellent communication and interpersonal skills. Strategic mindset with a focus on aligning with business objectives.

About the job

We are looking for an exceptional and driven Senior Director of IDMO Site Quality to spearhead the launch, scaling, and supervision of cGMP Operations at our cutting-edge multi-product cell therapy manufacturing facility. This facility will be pivotal in producing both autologous and allogeneic cell therapy products.
 
The successful candidate will lead the Quality Assurance and Quality Control (QA/QC) teams, collaborating with various departments to ensure safe and compliant manufacturing operations in line with cGMP regulations. This role involves enhancing the site’s Quality Management Systems (QMS) and ensuring adherence to regulatory standards. You will provide strategic direction to align with customer expectations and business objectives, requiring proven leadership to facilitate effective communication, coordination, and collaboration across diverse teams. This is vital for the successful production, testing, and release of products intended for patients.
 
This multifaceted role demands the ability to engage with all organizational levels, including Operations, MS&T, Process/Analytical Development, Supply Chain, Warehouse, Training, Engineering/Facilities, HS&E, and Finance.
 
The ideal candidate will thrive in a fast-paced, mission-driven environment and be ready to embrace a wide range of challenges as the company expands.

About Cellares

Cellares is at the forefront of innovation in cell therapy, committed to revolutionizing patient care through advanced manufacturing technologies. Our state-of-the-art facility in Bridgewater, NJ, is designed to support the growing demand for cutting-edge therapies, and we pride ourselves on our mission-driven culture.

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