Director of Quality Assurance

Beyond A Resume

Beyond A Resume is seeking a Full-time Director of Quality Assurance for our Biotechnology client in Frederick, MD.

Job Description:

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.

Reports To:

President and CEO

Job Responsibilities:

-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.

Job Requirements:

-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.

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