Position Summary:

• Develops Quality Management Program for Cell Therapy Program at CINJ.
• Develops and maintains all of GMP required documentation (including SOPs, controlled forms for manufacturing, personnel training, GMP facility use and maintenance, equipment maintenance, reagents validation, deviations, CAPAs etc).
• Approves the design and oversees the implementation of GMP Facility quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools.
• Monitors and arranges timely equipment preventive maintenance, services, calibration, certification.
• Monitors and arranges timely facility cleaning.
• Creates, maintains and revises all controlled documents for GMP Facility as required.
• Monitors all systems in the Facility for their performance status.
• Ascertains proper structure and function of all elements of GMP suite.
• Assists with development and validation of the Quality Control Tests for in-process and final product testing as well as for demonstration of the proper functioning of the equipment.

Minimum Education and Experience:

• Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
• Equivalent experience, education and/or training may be substituted for the education requirements.
• Minimum seven years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices GMP manufacturing setting or as an auditor of the regulatory agencies such as FDA, FACT etc.).
• Minimum ten years total relevant experience (includes any combination of: 1) specialized experience described above, and 2) clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices GMP manufacturing setting).
• Minimum five years management experience (includes supervision of Quality Assurance activities) or oversight, management or consulting services for the new development and implementation of the GMP units.

Required Knowledge, Skills, and Abilities:

• Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
• Expert knowledge of regulations and accreditation standards applicable to cGMP facility and cell therapy program.
• Strong work knowledges of quality system and regulatory requirements (21 CRF Part 11/210/211, 21 CFR 1271, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. id.
• Effective oral and communication skills.
• Expert ability to apply knowledge of, and interpret applicable Federal, State, Local and international regulations and standards, technical specifications, and other guidelines to evaluate compliance.
• Expert ability to analyze and interpret observational, operational, and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
• Expert ability to conduct studies and investigations for problem analysis, and risk assessments to assist with development of logical and well-documented recommendations for process improvement and corrective actions.
• Highly proficient at preparing and delivering clear, concise, and effective written and oral communications.
• Highly proficient at establishing effective interpersonal relationships to meet the goals of the organization.
• Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.

Preferred Qualifications:

• Familiarity with FACT (Foundation for the Accreditation of Cellular Therapy) Accreditation Standards.

Physical Demands and Work Environment:

Posting Number: 22ST0016

Location: Downtown New Brunswick