Quality Operations Manager

Hartmann Young; City of Albany (NY); On-site; USD 120,000 - 150,000; Full time

Job summary

Hartmann Young in Albany, NY is seeking an experienced Quality Operations Manager to oversee manufacturing quality in a cGMP API environment. The role drives compliance, continuous improvement and a strong quality culture across site operations.

Reporting to the senior quality leadership, you will lead quality oversight across manufacturing, batch disposition, deviation investigations and data integrity, partnering with cross-functional teams.

Qualifications

• Degree in Chemistry, Microbiology or related scientific discipline.
• Significant experience in FDA-regulated pharmaceutical manufacturing.
• Strong knowledge of cGMP for API manufacturing.
• Experience leading quality improvement initiatives.

Responsibilities

• Provide quality oversight across API manufacturing operations.
• Lead batch record review and batch disposition.
• Drive investigations, deviations and product impact assessments.
• Develop and improve quality systems and GMP compliance programmes.
• Champion data integrity and quality culture across site.
• Collaborate with Manufacturing, Quality and Technical teams.

Skills

Quality oversight

Batch review

Deviations investigations

cGMP knowledge

Leadership

Education

Bachelor's degree in Chemistry, Microbiology or related science

Job description

Albany, New York (On-site) - Relocation available for US citizens

Hartmann Young is partnered with a leading global CDMO specialising in small molecule pharmaceutical manufacturing to appoint a Quality Operations Manager.

This is an excellent opportunity for an experienced GMP quality professional to take ownership of manufacturing quality oversight within a highly regulated API environment, driving compliance, continuous improvement and quality culture across site operations.

The Opportunity

Reporting into the senior quality leadership team, you'll provide quality oversight across manufacturing operations, ensuring products are manufactured in accordance with cGMP requirements while supporting operational excellence across the site.

Working closely with Manufacturing, Quality Control and cross-functional teams, you'll lead initiatives that strengthen batch disposition, deviation management, data integrity and on-the-floor quality oversight.

Key Responsibilities

• Provide quality oversight across API manufacturing operations.
• Lead batch record review and batch disposition activities.
• Drive investigations, deviations and product impact assessments.
• Develop and improve quality systems, procedures and GMP compliance programmes.
• Champion data integrity and quality culture across the manufacturing site.
• Partner with operational teams to improve Right First Time and release performance metrics.
• Lead quality walkthroughs, identify improvement opportunities and implement corrective actions.
• Review and approve significant manufacturing deviations.
• Support customer interactions relating to manufacturing quality and batch documentation.
• Develop meaningful quality metrics and drive continuous improvement initiatives.

About You

We're looking for someone with:

• A degree in Chemistry, Microbiology or another relevant scientific discipline.
• Significant experience within an FDA-regulated pharmaceutical manufacturing environment.
• Strong knowledge of cGMP requirements within API manufacturing.
• Extensive experience in batch review, batch disposition and deviation investigations.
• Previous leadership or supervisory experience within Quality.
• The ability to work collaboratively across Manufacturing, Quality and Technical teams.
• Previous experience within a CDMO or contract manufacturing environment.
• Experience leading quality improvement initiatives within pharmaceutical manufacturing.

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