Manager, Quality Assurance

Description:

Manager, Quality Assurance Job Code 310MW Fate Therapeutics is seeking an experienced and motivated Manager of Quality Assurance to support Fate’s internal and external cGMP manufacturing operations. The successful candidate must thrive in a fast-paced team environment, have excellent communication, planning and organizational skills, and manage quality assurance activities to meet Fate’s priorities and timelines. The candidate must have experience and a proven track record of establishing and maintaining a quality management system to support GXP-compliant manufacturing operations and will be expected to effectively follow Fate’s SOPs and policies. This is a full-time position reporting to the Quality Assurance Senior Manager and is located at our corporate headquarters in San Diego, California.

Responsibilities:

• Conduct Quality review of internal and external production documentation, including batch records, analytical records and any supporting documentation to ensure compliance with cGMP and Fate policies and procedures.

• Perform Quality audits of contract organizations including manufacturers, laboratories, and suppliers.

Provide Quality Assurance oversight in support of product development and in-process, release and stability testing of raw materials, drug substance, and drug product.

• Lead QA support of tech transfer to CMOs and qualification of manufacturing activities.

• Proactively identify compliance issues, investigate and propose solutions, and leadclosure of deviations and completion of corrective and/or preventative actions.

• Perform day-to-day activities of Document Control including creation and/or revision, processing, routing, and releasing controlled documents.

• Provide QA support during manufacturing operations.

• Support Contract Manufacturing Operations as QA Person-In-Plant.

• Support QA Management with various projects as needed.

Qualifications:

• Minimum 5+ years of Quality Assurance related experience in a cGMP regulated manufacturing environment is required.

• Bachelor’s or advanced degree in a relevant scientific area preferred.

• Experience in identifying, writing, evaluating and closing investigations.

• Strong understanding and knowledge of GXP, ISO, and ICH concepts and guidelines and implementation of GXP in a Phase appropriate manner in conformance to US & EU standards.

• Demonstrated ability to work independently, prioritize, and complete activities in a timely manner; self-motivated and willing to accept temporary responsibilities outside of initial job description.

• Strong verbal and written communication skills and ability to work with others in a positive and collaborative manner.

Working Conditions and Physical Requirements:

• Will require 10%-50% travel • Some weekend and/or evening hours may be required

• Full-time onsite work at corporate headquarters in San Diego, CA The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.