Senior Director, Quality Control

Arbeitsbeschreibung

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.

Kite is seeking a highly motivated individual to join our team as Senior Director, Quality Control at our commercial manufacturing facility in Urbana, MD. You will be responsible for leading a commercial manufacturing site Quality Control organization, including analytical, microbial, stability and sample management groups and activities for cell therapy products.

Responsibilities include (but are not limited to):

• Manage analytical, microbial, stability and sample management groups to ensure timely testing.  Manage method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to a contract-testing lab.
• Advance technology integration in the labs and methods to drive COGM reduction.
• Coordinate the development and implementation of group strategy for Kite portfolio of products and/or across quality sub-functions.
• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of cGMP.
• Establishes and publishes Key Performance Indicators to track cGMP compliance for the Quality Control function. Capture metric information for use in continuous improvement of areas of responsibility.
• Works with senior management, develops plans and strategic direction for the team. Collaborates cross-functionally and geographically with partners to ensure that quality control processes are aligned to the needs of Kite, ensuring that standard methodology, compliance and alignment with business needs.
• Collaborate with Regulatory agencies as the need arises representing Kite to authorities and regulatory inspectorates in matters relating to GMP. Leads standardization and harmonization of Standard Operating Procedures, using existing Kite Quality Control Systems. Participate in inspections and audits of the laboratories.
• Leadership of QC functional groups to ensure timely testing. Oversight of laboratory training programs.
• Collaborate and maintain routine interaction with Analytical development laboratories, as well as external contract testing laboratories.
• Responsible for conducting laboratory investigations, OOS, OOT. Generation of CoAs for product release
• Draft analytical and stability sections of global regulatory submissions
• Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility. Frequently update management on trends. Implement corrective action plans when vital. Tracking of data from external contract manufacturers and laboratories to complete lot disposition.
• Establish user requirements for purchase, qualification of Kite’s QC analytical equipment. Work with internal and external resources to maintain equipment in an efficient state. Develop, revise and review SOPs, qualification/validation protocols and reports.
• Monitor the GMP systems currently in place to ensure compliance with documented policies. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

Basic Qualifications:

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 12+ years’ experience of Quality Control Biopharmaceutical experience OR
• Master’s Degree and 12+ years’ experience of Quality Control Biopharmaceutical experience OR
• Bachelor’s Degree and 14+ years’ experience of Quality Control Biopharmaceutical experience OR
• High School Degree and 18+ years’ experience of Quality Control Biopharmaceutical experience

Preferred Qualifications:

• QC lab management experience.

• Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Quality Control, GMPs, bioanalytical method validation
• Strong knowledge of GMP, SOPs and quality control processes
• Strong knowledge of technical writing for BLA, IND. 
• Identifying, writing evaluating and closing OOS’s and investigations
• Strong knowledge of cell culture techniques
• Equipment and utility IQ/OQ/PQ/PV
• Proficient in MS Word, Excel, Power Point and other applications
• Ability to communicate and work independently with scientific/technical personnel.
• 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
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Excellent interpersonal, verbal and written communication skills