Customer Quality Lead, QA at Hartmann Young Customer Quality Lead, QA at Hartmann Young in Rensselaer, New York Posted in 7 days ago.

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full-time Customer Quality Lead, QC - CDMO Hartmann Young is partnered with a global contract development and manufacturing organisation (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 Assurance to join the team in Albany, New York. The Role The Customer Quality Lead serves as the primary quality contact for customers, ensuring compliance, product quality, and timely resolution of customer enquiries, investigations, complaints, and quality commitments. This role partners with cross-functional teams to support customer satisfaction, regulatory compliance, continuous improvement, and successful product lifecycle management. Duties Provide quality support to internal and external customers, acting as a key point of contact for customer-related quality matters. Lead and review product investigations, complaints, root-cause analyses and CAPAs, ensuring appropriate follow-up and effectiveness. Coordinate quality activities including change controls, deviations, product reviews and validation activities. Ensure customer and regulatory commitments are delivered on time, escalating risks and delays where necessary. Work closely with QA, QC, Regulatory and other stakeholders to address customer requests and support regulatory submissions. Support customer audits, meetings and quality-related activities throughout the product lifecycle. Support new product introduction and development activities, ensuring appropriate QA and QC input. Manage quality agreements and ensure they remain current and aligned with customer requirements. Drive GMP compliance and continuous improvement initiatives to strengthen quality processes and customer satisfaction. quality expectations, audit learnings and best practices across the wider quality organisation. The Person Minimum 10-15 years in QA, API process development, technical services, or GMP Compliance experience in the pharmaceutical industry at USFDA regulated facilities. Working experience with managing 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 manufacturing operations. USFDA inspection experience (e.g., participant or has interacted with Investigators). Excellent communication and organisational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross-functionally across internal stakeholders. Proficient in building consensus, negotiating, and escalating issues; and proven customer service. Good understanding of the importance and use of quality metrics. If this sounds like something of interest, we'd love to hear from you! Apply today, or feel free to reach out directly. Due to the high volume of applications, we cannot guarantee a response with detailed feedback. Please note, this is a full-time onsite position - relocation support is available for this opportunity.