Job Description Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
We are seeking a highly motivated individual to join us as a Senior (Lead) Technical Quality Assurance Specialist (equivalent to a manager level position) to support the startup of Kite's brand new, state of the art, commercial Cell Therapy facility currently under construction in Frederick, Maryland. In this position, you will provide Quality Assurance oversight of Commercial Manufacturing, Materials Management, and Quality Control areas.
In this role, you will assist with managing the activities of the plant Quality Assurance department to ensure conformance to Kite Pharma quality standards and government regulations.
You will also ensure compliance with the quality system procedures and identify and assess regulatory and quality risks in activities. This role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on behalf of Kite Pharma.
Responsibilities (include but are not limited to):
Work closely with and provide quality oversight across functions (Manufacturing, Supply Chain, Site QC, Process Development, Site QA and) within Kite and externally to assure compliance and strong relationships.
Review and approve functional SOPs and work instructions.
Develop process maps / models working with automation, manufacturing, QC and engineering disciplines.
Establish quality operation processes such as raw material release, batch release, and quality operations on the floor.
Create data flow diagrams documenting interactions with manufacturing systems, such as ERP (Oracle EBS) Manufacturing floor equipment and Automation Systems.
Review master data, design of Generic Manufacturing Batch Records (GMBRs), manufacturing batch records (MBR), electronic logbooks and Parameterized Value Lists (PVLs).
Ensure design of GMBRs batch records allow for QA batch record review by exception..
Once the site is operational perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to: o Batch documentation review and ensure resolution of issues to release product. o Review and approval of product-related Deviations and CAPAs o Disposition of raw materials and product lot o Review and approval of Change Controls and ensure proper maintenance and approval of cGMP documents. Ensure change controls are initiated, evaluated and implemented appropriately for all regulated changes.
Support quality assessments of internal operations to analyze quality compliance and assess risk.
Provide QA guidance on product development projects and technical transfer activities.
Support Management Review activities and oversee trending of key quality, product and GMP metrics
Review and approve Deviation investigations and CAPAs, and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions
Support regulatory inspections, internal audits, and external audits from partners.
Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.
Support Quality on the floor process.
Ensure process control measures are in place and followed in product manufacturing.
Maintain and reports monitoring and control metrics for process performance and product quality.
Up to 10% domestic travel
Ability to work (10 hours/day, 4 days a week) in near future.
Perform other duties as assigned
7+ years of experience in a GMP environment with BS degree in the biological sciences or related field
5+ years of experience in a GMP environment with MS degree in the biological sciences or related field
In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
Proficient in cGMP regulations, quality systems and regulatory requirements.
Experience writing, evaluating and closing investigations, CAPAs and change control records.
Experience with conducting and managing internal and external audits.
In-depth understanding and application of qualification and validation principles, concepts, practices, and standards.
Ability to effectively negotiate and build collaboration among individuals.
Demonstrated ability to develop, coach, and mentor key employees
Proficient in MS Word, Excel, Power Point and other applications.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Willingness to think outside of the box and adapt best practices to a small, but growing environment
Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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