What are the responsibilities and job description for the Quality Disposition Supervisor position at Hartmann Young?
Supervisor, Quality Disposition - 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 Quality Disposition Supervisor to join the team in Rensselaer, New York.
The Role
You will lead the Quality Disposition team, overseeing the review and release of intermediates, APIs and incoming materials to ensure products are dispositioned in a compliant and timely manner. You will act as the site lead for batch disposition activities, ensuring batch record reviews are completed to GMP standards, deviations, CAPAs and change controls are appropriately assessed and closed, and quality decisions are supported by strong technical and scientific rationale. You will also work cross-functionally to drive continuous improvement initiatives, develop reviewer qualification programmes, and support customer audits and regulatory inspections.
The Person
Required
- Bachelor's Degree in a scientific discipline or related field;
- Minimum of 6 years of GMP experience within an FDA-regulated pharmaceutical environment;
- Minimum of 4 years of Quality Disposition or Batch Release experience in a supervisory role;
- Strong knowledge of batch record review, deviations, CAPAs and change control processes;
- Previous experience leading Quality teams within a commercial GMP manufacturing environment.
Preferred
- Experience working within a CDMO environment;
- Previous involvement in customer audits and regulatory inspections;
- Experience developing training or qualification programmes;
- Strong understanding of batch release and product disposition processes.
The ideal candidate will demonstrate excellent leadership and communication skills, with the ability to make sound quality decisions in a fast-paced GMP environment. They will possess a strong understanding of cGMP requirements, FDA regulations, data integrity principles and quality systems, together with exceptional attention to detail and the ability to effectively manage multiple priorities while working collaboratively across cross-functional teams.
If this sounds like you, please apply here or reach out on joe.boyd@hartmannyoung.com - we'd love to hear from you!
Please note - relocation support is available for this position.