Head of QA
- Baltimore MD area
A leading biologics/bioscience organization is actively seeking a Head of Quality Assurance (QA) to join their team. This role is responsible for managing all aspects of quality assurance and compliance relevant to regulatory requirements. The Head of QA will also be tasked with developing strategy for compliance to medical device and drug regulations.
The Head of QA will have the following responsibilities:
- Offers support and oversight for aseptic operations, making sure product meets both US and international aseptic processing requirements
- Supports facility and quality systems compliance with internal company requirements, while participating in developmental action plans to make improvements to quality processes
- Handles all deviation and compliant investigations, ensuring that any issues are investigated and resolved in a timely matter
- Develops cGMP documents, including SOPs, batch records and specifications
- Leads regulatory and client audits as the aseptic subject matter expert
The Head of QA should have the following qualifications:
- Bachelors degree in life science or related field
- Extensive GMP experience within an aseptic filling or biologics environment
- Strong understanding of aseptic filling and drug processing/medical device regulations
- ASQ certification a plus
- Understanding of endotoxin (LAL) testing
- Ability to manage large teams