Associate Director, Quality Control
- Maryland
One of the top global suppliers to pharmaceutical, biotechnology, and specialty ingredient markets is looking for a Head of Quality! This company is one of the leaders that provides products and services that range from API to microbial control solutions, to personal and nutritional care ingredients to agriculture products with over 14,000 employees worldwide. You will be leading and supporting Audits and Regulatory Inspections at the Maryland Site, and lead the quality organization. You will accomplish corporate business objections through means of the development of the site quality systems.
The Associate Director, Quality Control will have the following responsibilities:
- Responsible for the daily operations of QC Testing Services including budget development and management.
- Directs management for testing laboratories that conduct final release testing for raw materials, research products and early development through late stage clinical trial cell therapy products.
- Ensures tests are completed on time and right the first time.
- Participates in technology transfer of customer documentation and testing protocols. Participates in client meetings. Participates in compliance audits.
- Oversees company's test sample receipt laboratory that tracks all internal QC testing, external testing services and contract manufacturing testing projects.
- Assists Department Managers / Supervisors with out of specification investigations, technical troubleshooting / problem solving.
- Develops and maintains effective working relationships with key internal / external customers.
- Assists with implementation of department test methods, writes and revises bills of materials, prepares monthly reports, and participates in regulatory audits.
- Understands and analyzes Key KPIs and cost center financials - works to ensure most efficient and economical department.
- Utilizes Lean and Six Sigma (OE) tools.
- Responsible for maintaining staff by recruiting, selecting, orienting and training employees; leads and mentors staff for further career development.
The Associate Director, Quality Control will have the minimum requirements:
- 5 + years QC experience in a Biotech company
- Prior Mnagement experience.
- Bachelor's degree in Chemistry or closely related field.