Director - Quality Control
- Location: Atlanta, GA
- Working situation: Hybrid
- Level: Director
Our client, a mid-sized, successful pharmaceuticals firm, is working to produce innovative biologic drug therapies with multiple products in pipeline from pre-clinical to the commercialization stage.
The Director - Quality Control will lead our Quality Control Director and oversee all aspects of Quality Control for the pharmaceutical client. This individual will work closely with senior leadership to ensure that quality standards are met and that our products are in compliance with all applicable regulations.
The Director - Quality Control will:
- Manages the implementation/maintenance/continuous improvement of Quality Systems.
- May perform quality metric trending as required.
- Authors risk assessment as required to support Quality Control Operations.
- Collaborates with Quality Control testing groups to author and/or review standard operating procedures, protocols, reports as required.
- Represent Quality Control on project teams.
- Maintain a safe, efficient, functional and compliant laboratory according to regulatory, site and corporate guidelines.
- Supports internal and external audits as required, including drafting audit responses in coordination with department management and subject matter experts.
The Director - Quality Control has the following qualifications:
- S. degree in any scientific field. An advanced degree would be a plus.
- Minimum of 10 years of Quality Control experience in the Pharmaceutical/Biotech industry within a GMP regulated environment, including experience in a leadership role.
- Expert knowledge of industry standards and regulatory requirements, including cGMP, FDA, and ICH guidelines
- Strong leadership experience not limited to mentoring, project management, and training of QC related personnel.
- Competitive 401K program, health insurance, and HSA accounts
- Long term incentives in the terms of equity or stock at this level
- Flexible hybrid working model