$200K — $250K *
Pharma Quality Assurance Manager
Position Title: Pharma Quality Assurance Manager
Position Type: Full-Time
Job Type: Experienced
Reporting To/Department: Senior Vice President, Quality
Lumicell is seeking a highly motivated Pharma Quality Assurance Manager to work in a dynamic, fast-paced start-up environment on a combination drug-device product. Lumicell is developing a breakthrough surgical guidance technology platform consisting of a proprietary drug that is activated by the micro-environment of cancerous tumors, a custom fluoroscope that allows a surgeon to visualize activated drug, and a software system that gives a real-time prediction of tissue likely to be cancerous. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development.
The Pharma Quality Assurance Manager will lead the development of corrective action plans and monitor implementation. This position will contribute to the overall development, implementation and execution of quality systems in support of the drug manufacturing.
The Pharma QA Manager role consists of oversight of all Quality and compliance aspects of a pharmaceutical program as part of a combination medical device. This includes exposure and fluency with Quality Management Systems and requirements, supplier quality maintenance, review and approval of Deviations and CAPA, release of clinical product, and oversight of suppliers using cGMP best practices. Also, knowledge of clinical quality and global GCP standards is an asset. Important elements of this role also include: Investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering Validation, and other personnel necessary to complete the investigation
Conduct weekly reviews of Drug Program documentation, Quality records, and milestone tasks.
Assist in the review for preparation of New Drug Application (NDA).
Create new or redline pre-existing standard operating procedures (SOPs) to bolster Drug Program compliance.
Liaise with Drug Program vendors on maintenance activities, as well as continuous improvement.
Review and approve testing reports, specs, batch record amendments, etc.
Lead investigations of deviations
Provide cGMP compliance support to manufacturing by investigating and resolving quality issues
Provide expert guidance to Clinical, Drug, R&D, and other departments regarding quality and cGMP issues to ensure compliance with regulated standards
Routinely provides quality metrics for management review
Support FDA inspections, third party audits, and Regulatory submissions as they relate to the drug.
Education and Required Experience:
Pharmaceutical quality assurance experience required (10+ years)
Drug supplier audit experience
Expertise with ICH Q3, Q7, Q9
Fluent with Quality Management Systems (eQMS); Arena or Trackwise preferred
Deviation, CAPA, NCR experience required
Root Cause Analysis and investigation training (DMAIC, 8D, etc.) required
Experience reviewing drug specifications
SOP review and approvals and editing required
FDA submission experience preferred
Combination medical device experience preferred
This position does not currently have supervisory responsibilities.
Position Type/Expected Hours of Work
This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
Some travel may be expected for this position including observation of hardware being used in the field, meetings with outside vendors or collaborators, testing of equipment at outside labs, conference and or training events.
Lumicell is an equal opportunity employer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice
Valid through: 11/25/2020