Customer Quality Lead - Quality Control

Customer Quality Lead, QC - 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 Customer Quality Lead in Quality Control to join the team in Albany, New York.

The Role

As the QC Customer Quality Lead, you will provide leadership and oversight for customer-facing QC activities, ensuring analytical deliverables are completed on time and in compliance with regulatory and quality requirements. You'll be the primary point of contact for QC-related enquiries, building strong customer relationships, coordinating cross-functional teams, and supporting method transfers, stability programmes, regulatory responses, and analytical activities for new and commercial products. You will monitor project progress, proactively manage risks and escalations, facilitate customer meetings and audits, and collaborate with internal stakeholders to deliver high-quality, customer-focused solutions across the product lifecycle.

The Person

• Minimum Master of Science degree in Chemistry or a related field;
• 10+ years experience in QC, QA, API process development, technical services, or Quality for QC experience in the pharmaceutical industry at USFDA & EMA regulated facilities;
• Required working experience with global customers and global cross-functional teams;
• Broad knowledge of cGMP, FDA, and international regulations (e.g., 21 CFR 11, 210, 211, 820, EU GMP, ICH Q7), Quality Systems for active pharmaceutical ingredients (APIs), and familiarity with guidelines (e.g., FDA, ICH);
• Knowledge of pharmaceutical processes;
• USFDA inspection experience;
• Proficient in building consensus, negotiating, and escalating issues;
• Good understanding of the importance and use of quality metrics.

The ideal candidate will have excellent communication and organizational skills, as well as negotiation, influencing and collaboration skills. Ideally, you'll have a demonstrated ability to work cross-functionally across internal stakeholders.

Please note - relocation support is available for this position.