Quality Control Manager

Hartmann Young is partnered with a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotechnology companies to support the development, manufacture, and delivery of therapies for patients. We are looking for a QC Laboratory Remediation Manager to join the team in Albany, New York. The Role You will lead quality control laboratory remediation and continuous improvement initiatives to strengthen regulatory compliance and operational performance. You will also assess gaps in laboratory systems, identifying and implementing practical, compliant solutions for routine operations, supporting the implementation of a Laboratory Information Management System (LIMS), and developing robust Corrective and Preventive Action (CAPA) plans to address key improvement areas. The Person Required Bachelor’s Degree in Chemistry or relevant field; Minimum of 5 years of relevant related work experience plus 2 years in a team leadership role; Investigations experience including root cause analysis, writing, and CAPA identification; Good understanding of GMP requirements for QC operations; Previous experience managing a QC team in a commercial product GMP environment. Preferred Advanced degree in Chemistry or related field; Investigations experience in a laboratory setting; Pertinent training/courses; Experience in a cGMP QC environment. The ideal candidate will show strong initiative, a results-focused approach, and the ability to effectively leverage team resources. They possess expert knowledge of cGMP, USP, EP, FDA GMP regulations (including 21 CFR Parts 211, 820 and/or 600), and relevant ISO standards (ISO 9001 and 13485), together with a strong technical understanding of laboratory techniques and data interpretation. Excellent organisational skills, with the ability to manage multiple priorities effectively, are essential. Please note - relocation support is available for this position. #J-18808-Ljbffr