Quality Control Manager

Quality Control Manager - CDMO

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 Quality Control Manager to join the team in Rensselaer, New York .

Please note: This is a permanent night shift position. Candidates must be able to work night shifts on an ongoing basis .

The Role

The Quality Control Manager is responsible for overseeing the Quality Control function at the site, leading laboratory operations and ensuring testing, investigations, documentation and reporting are completed in compliance with applicable regulatory requirements. The role will manage QC teams, drive laboratory performance and inspection readiness, and ensure the effective delivery of both routine and non-routine analytical activities.

Day to day, you will:

• Manage and prioritize testing and operations across Quality Control teams, covering incoming materials, in-process samples and final products;
• Lead and develop a team of QC analysts, technicians and supervisors, including performance management, training, productivity and development;
• Ensure QC activities are completed in accordance with company standards, regulatory requirements, SOPs and cGMP;
• Drive schedule adherence and Right First Time performance across the laboratory;
• Maintain laboratory inspection readiness and play a key role in regulatory inspections;
• Manage customer requests relating to Quality Control activities;
• Ensure deviations and investigations are initiated and completed within required timelines;
• Manage investigations including OOS, deviations, change controls and CAPAs;
• Ensure effective shift handovers and consistent operational standards across the QC function;
• Organize workloads and coordinate multiple projects against established objectives, timelines and deadlines;
• Oversee pharmaceutical analysis supporting manufacturing operations;
• Mentor and train team members across analytical techniques and laboratory equipment.

The Person

• Bachelor’s degree in Chemistry, Analytical Chemistry, or related field;
• Minimum 5–8 years’ experience in a GMP or GLP environment working with chromatography including HPLC, UPLC and GC;
• Extensive experience in analytical method development and/or validation;
• Minimum 2 years’ professional management experience;
• Experience playing a key role during regulatory inspections;
• Expert knowledge of cGMP, USP, EP and FDA regulations;
• Strong experience with OOS investigations, deviations, change controls and CAPAs;
• Strong leadership, organizational and communication skills;
• Proficiency in HPLC and GC method development and validation, alongside experience with a range of additional analytical techniques and equipment.

The ideal candidate will be a strong QC leader who can balance technical expertise with operational management. They will be comfortable driving laboratory performance, developing teams, maintaining inspection readiness and ensuring the QC function consistently delivers against quality, regulatory and operational expectations.

If this sounds like you, please apply here or reach out directly - we'd love to hear from you!

• Relocation support is also available for this role.