Quality Assurance Manager, GMP

Job Code: 058

The Quality Assurance Manager position is responsible for establishing the compliance direction for a GMP manufacturing site by developing a GMP quality management system designed to support a stem cell therapeutic product. The position is responsible for adapting current systems for use in a GMP facility and ensuring the adherence through audits and inspections. This position has the possibility to work remotely.

Skills and Responsibilities:

• Hire, manage, and develop Quality Assurance staff.
• Adapt current systems for compliance to FDA GMP regulations and track and trend data for CAPA, deviations, complaints, investigations, and vendor non-conformance.
• Assist in development of facility commissioning and validation protocols. Oversee the work of vendors/consultants in supplying required validation documentation.
• Provide regulatory guidance on cross-functional product development and technology transfer teams.
• Perform audits of production batch records, quality control data, and executed qualifications and validations.
• Perform inspections of internal quality systems for compliance to SOPs.
• Perform, as necessary, qualification audits of vendors, OEM partners, and service providers.
• Provide new employee and annual regulatory training.
• Release/reject raw materials and finished product for manufacturing and distribution, respectively.
• Manage document control and archives.
• Maintain current knowledge of regulatory and industry trends.
• Perform related duties, as necessary.

Qualifications:

• A minimum of 5 years experience relevant to quality assurance in a GMP-regulated facility
• A BS degree in biology or life science related field
• In-depth knowledge of sections of the Code of Federal Regulations that apply to cell therapeutics, HCT/Ps, and gene therapeutics (21 CFR 210, 211, 600 and 1271) in addition to related guidance documents
• Working knowledge of the State of California FDB Drug Manufacturing Licensure requirements
• Experience working with or at a facility that specializes in stem cell therapy desired
• 40 - 50% travel required between Madison, Wisconsin, and the state of California
• Excellent written and oral communication skills
• Proven ability to manage systems
• Strong computer skills

CDI is an Affirmative Action / Equal Opportunity Employer.

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