Customer Quality Lead - Quality Control

Hartmann Young Limited; City of Albany (NY); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Hartmann Young Limited in Albany, NY, seeks a QC Customer Quality Lead to oversee customer-facing QC activities and ensure analytical deliverables meet regulatory and quality requirements. You will be the primary contact for QC inquiries and will coordinate with cross-functional teams on method transfers, stability programmes, and regulatory responses.

The ideal candidate has a MS in Chemistry and 10+ years in QC/QA within FDA/EMA-regulated facilities, with strong communication and negotiation

Qualifications

• 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;
• Proficient in building consensus, negotiating, and escalating issues;
• Good understanding of the importance and use of quality metrics.

Responsibilities

• Provide leadership and oversight for customer-facing QC activities.
• Coordinate cross-functional teams, supporting method transfers, stability programmes, regulatory responses, and analytical activities for new and commercial products.
• 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.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

Quality systems

FDA/EMA regulations

Project management

Education

Master of Science in Chemistry

Job description

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;
• 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.