Customer Quality Lead, QA

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

Job summary

Hartmann Young in Albany, NY is seeking a Customer Quality Lead in Quality Assurance to act as the primary quality contact for customers. You will ensure compliance, address investigations and CAPAs, and coordinate activities across QA/QC and Regulatory teams, including validation and change controls.

The ideal candidate has 10–15 years in QA within US FDA-regulated pharma facilities, strong communication, and a proven ability to lead cross-functional teams and drive continuous improvement in

Qualifications

• Minimum 10-15 years in QA, API process development, technical services, or GMP Compliance experience in the pharmaceutical industry.
• Experience managing global customers and cross-functional teams.
• Broad knowledge of cGMP, FDA, and international regulations (21 CFR 11, 210, 211, 820; EU GMP; ICH Q7).
• Knowledge of pharmaceutical manufacturing operations and quality systems for APIs.
• USFDA inspection experience or interaction with Investigators.
• Strong communication, organizational, negotiation and collaboration skills across functions.

Responsibilities

• Provide quality support to internal and external customers, acting as a key contact for customer-related quality matters.
• Lead and review product investigations, complaints, root-cause analyses and CAPAs, ensuring 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 input.
• Manage quality agreements and ensure alignment with customer requirements.
• Drive GMP compliance and continuous improvement initiatives to strengthen quality processes.
• Share quality expectations, audit learnings and best practices across the wider quality organisation.

Skills

QA leadership

Customer quality

FDA compliance

Cross-functional

Quality metrics

Negotiation

Job description

Please note, this is a full-time onsite position - relocation support is available for this opportunity.

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.
• Share 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.

Due to the high volume of applications, we cannot guarantee a response with detailed feedback.