Quality Assurance Manager
Genelux Corporation (www.genelux.com) is a privately-held, clinical stage biopharmaceutical company that has developed a proprietary oncolytic virus based technology platform and a deep pipeline of products with broad applications for cancer detection and therapy.
The Quality Assurance Manager (QA Manager) will provide quality oversight for development, cGMP manufacturing and GMP testing of Drug Substance, Intermediate Materials, and product intended for clinical use. The QA Manager will be responsible for applying GMP controls and monitoring quality expectations for product development in a phase appropriate manner. Primary responsibilities include review of GMP records for product release and support of quality systems activities related to training, internal/external audits, investigations, CAPA and document control.
Quality Assurance Manager
ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned.
- Implement Quality System.
- Implement and Manage Document Control process.
- Manage Quality Control.
- Develop and implement procedures, programs and policies that support GMP operations.
- Coordinate and conduct training of personnel.
- Implement raw materials receiving and controls.
- Conduct vendor/supplier qualification.
- Prepare Certificates of Analysis for manufactured products.
- Conduct internal quality audits.
- Conduct outside quality audits.
- Report quality status to management.
- Submit compliance reports to and from regulatory agencies, as needed.
- Perform all duties and responsibilities in accordance with regulatory requirements, cGMP regulations, SOPs, and other applicable guidelines.
- BS/BA in Biology or related field.
- 5 years of experience within the life sciences industry, preferably pharmaceuticals, with 3+ of those years in a progressively responsible QA role.
- QSM and GMP Training and experience.
- Experience implementing and managing a Document Control System.
- Experience implementing and managing Quality Systems.
- Ability to implement raw materials receiving and controls.
- Proficiency with Microsoft Office Applications.
- Effective organizational and time management skills.
- Ability to communicate effectively in writing, and verbally.
- Biologics Experience
- Conduct of Risk Analyses and CAPA
- Quality Control of pharmaceutical agents.
- Local travel will be required regularly. Overnight travel may be required as needed.
- Travel may be via commercial airline and/or automobile.
- Valid Driver License.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to stand; walk, use hands and talk or hear. The employee is frequently required to reach with hands and arms. The employee is frequently required to walk, and occasionally stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.