The Quality Assurance Supervisor will have in-depth experience in drug substance and drug product manufacturing. Reporting to the Sr. Director, Quality Assurance, the QA Supervisor will support in Quality oversight and support all company departments, including (but not limited to) Production & Manufacturing, Quality Control and Bioanalytical Lab, R&D, for the manufacturing and testing of non-clinical, clinical, and commercial products.
Essential Duties and Responsibilities include but are not limited to the following:
Writes, reviews, and approves GMP/GLP/GCP (GxP) documentation (i.e., SOPs, protocols, reports). Provides QA oversight over GxP activities.
Performs inspections for GLP studies. Maintains the Master Schedule and provides QA Statements and QA Statements of Compliance to support nonclinical studies.
Reviews and approves executed batch records and associated test data related to the manufacturing of drug substances and drug products.
Aids in process improvements with respect to quality, including change control, deviations, OOSs, and CAPAs.
Monitors the various quality systems [i.e., change controls, deviations, investigations (OOSs), corrective and preventive actions (CAPAs)] for timely processing and appropriate closure.
Coordinates the review and disposition of raw materials, intermediates, drug substances and drug products.
Conducts Quality monitoring of in-house manufacturing operations, including responsibility for reviewing and approving master production and control records, and reviews and approves master batch records.
Supports equipment, utility, and facility qualification activities, including the equipment calibration and maintenance programs.
Performs Quality review of test method validation, cleaning verification/validation, stability studies and process validation documents.
Utilizes tools to perform risk assessments; tracks and reports metrics to Executive Management (CEO) for Quality Management Review.
Supports regulatory submissions.
Will perform audits (internal assessments, external assessments, third party assessments, regulatory inspections).
Delegates work activities to direct reports with regard to quality oversight.
. Requirements:
Position Requirements and Experience:
BA/BS in biological sciences, Chemistry or relevant discipline
A minimum of 5 years’ experience in the pharmaceutical/biotech industry, preferably experience in a GMP environment supporting manufacturing of product for clinical and/or commercial use
2 years+ of increasing responsibility and relevant QA experience in a pharmaceutical / biotechnology environment supporting GMP manufacturing of drug product for pre-clinical, clinical, and/or commercial use.
Working knowledge of cGMP principles with respect to appropriate regulatory requirements (FDA, ICH guidelines)
Experience in reviewing cGxP related documents (batch records, SOPs, test methods, validation/qualification documents, logbooks, forms)
Experience in writing/developing and reviewing change controls, deviations, investigations, CAPAs plans
Knowledge of drug development process
Experience in product justification, process validation, and risk assessment
Experience to identify technical manufacturing problems and suggest resolution of issues
Independently analyzes/resolves moderate to complex issues
Initiative and is held accountable to project goals in a fast-paced environment
Proficient in application of QA principles, concepts, industry practices and standards
Great problem-solving skills, effective written and verbal communication skills
Excellent documentation skills and is detail-oriented
Organized and able to manage multiple priorities
Works independently, as well as, in a team environment
Working knowledge of MS Office Suite (Word, PowerPoint, Excel)
Physical Demands/Work Environment:
Work hours will support Manufacturing work schedule to ensure timely issuance of production batch records and supporting documentation (labels, packaging components).
Has the ability to work in cleanroom environment
Has the ability to sit for long periods of time