job summary: Director, Quality (QA/QC)
This person will work in the Quality Department and oversee the direction and management of Quality Assurance and Quality Control departments. This person will interact with regulatory agencies and customers as needed. Interaction with other departments and support manufacturing operations for GMP batch manufacture and QC laboratory analytical testing as required.
location: Cranbury, New Jersey
job type: Permanent
salary: $160,000 - 170,000 per year
work hours: 9 to 5
- Development of Quality framework to support commercial and clinical supplies of pharmaceutical products.
- Management of Quality Assurance and Quality Control Units within the company.
- Support all cGMP activities occurring at the facility.
- Facilities regulatory and customer audits.
- Oversees setting and enforcement of training requirements.
- Insure appropriate staffing requirements within Quality departments.
- Review & give guidance on issues to resolve problems and maintain effective control within the facility.
- Education: BS/MS in a Pharmaceutical, Biological, Chemical science or related field with 10 years experience in a Pharmaceutical QA Managerial/Supervisory position.
- Knowledge/Skills: Working knowledge of computers, Word, Excel, Outlook, PowerPoint. Communications, oral, written, negotiations and interpersonal skills.
- Knowledge of GMP regulations, Parts 210, 211 of the Federal Register, ICH Guidelines and practices. Having an understanding of pharmaceutical manufacturing requirements including facilities, systems and equipment is required. Understanding of laboratory operation for Quality Control and analytical work including basic knowledge of methods and analytical instruments such as HPLC, GC, TOC, UV, FTIR, Dissolution, Karl Fisher moisture determination, pH, conductivity is required.
skills: Quality control, Quality Assurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.