$80K — $100K *
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 Associate Director, Quality Assurance and is located at our corporate
headquarters in San Diego, California.
• 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 lead
closure 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.
• Minimum of five years of Quality Assurance experience in a cGMP regulated
• manufacturing environment is required.
• Bachelor’s or advanced degree in a relevant scientific area.
• 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
• Demonstrated ability to work independently, prioritize, and complete activities in a timely
manner; self-motivated and willing to accept temporary responsibilities outside of initial
• 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 25%-50% travel
• Some weekend and/or evening hours may be required
• Full-time onsite work at corporate headquarters in San Diego, CA
Valid through: 4/30/2021
$80K — $100K
8 days ago
$150K — $200K + tbd