Beyond A Resume
Beyond A Resume is seeking a Full-time Director of Quality Assurance for our Biotechnology client in Frederick, MD.
The Director of Quality Assurance must be highly motivated with an entrepreneurial spirit for a leadership position in biopharmaceutical development programs that include biosimilar and biodefense products. The Director of Quality Assurance will lead all aspects of Quality including R&D, GLP, and GMP activities.
President and CEO
-Serve as a key member of the Quality leadership team.
-Qualify and validate (as appropriate) methods for GMP release of monoclonal antibodies and functional leadership including managing internal and outsourced QA staff and the Quality Control department.
-Foster and maintain a culture of Quality at BioFactura and assure the site quality training system is effective.
-Provide strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities.
-Provide support for audits and regulatory inspections.
-Approve master batch records, procedures, and protocols.
-Perform and oversee the lot disposition process.
-Perform change control assessments to Quality Systems including document management, change control, and CAPA.
-Approve Deviations and CAPAs and ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address the root cause.
-Develop and implement annual quality plans, departmental goals, action plans, and budgets.
-Independently report on quality metrics to executive management.
-Responsible for talent management including recruitment, selection, development, training, and retention of both outsourced and in-house quality staff, and ensuring that proper quality skill sets and competencies are consistent with business and technology plans.
-Collaborate with process development, manufacturing, engineering, corporate, and clinical groups to ensure site Quality.
-Develop procedures and processes for efficient oversight and release of GMP consumables, disposables, raw materials, and final products.
-B.S., M.S., and/or Ph.D. degree in life sciences.
-A minimum of 10 years of hands-on experience in Quality Systems management.
-Prior supervisory experience.
-Experience in the preparation and delivery of oral and written presentations, and participation in the preparation and submission of regulatory documents such as the IND application and BLA, are required.
-Significant experience with the development and regulatory licensure of biosimilar products is highly desired.
-Strong knowledge of cell culture-based recombinant protein process development, scale-up, and GMP manufacturing are required to specifically include the development of therapeutic monoclonal antibodies (mAbs).
-Comprehensive knowledge of quality system requirements such as US FDA GMP, GCP, EMA, and ICH guidelines and has a proven track record of successfully implementing these requirements to ensure patient safety and compliance with FDA and other applicable health authorities’ requirements.
To apply for this job email your details to firstname.lastname@example.org