Sr. Director, Head of Quality Control

Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work.

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

Responsibilities include (but are not limited to):

• Provide direction for analytical, microbial, technical services and sample management groups to ensure timely testing. Develop method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development or to QC as well as the transfer and validation of methods between manufacturing sites.
• Advance technology integration in the labs and methods to cultivate COGM reduction.
• Coordinate the development and implementation of group program 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 stakeholders, 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. Supports standardization and harmonization of Standard Operating Procedures, using existing Kite Quality Control Systems. Participate in inspections and audits of the laboratories.
• Direction of QC functional groups to ensure timely testing. Oversight of laboratory training programs.
• Collaborate and maintain routine interaction with 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 stakeholders 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 desired.

Basic Qualifications:

• Advanced scientific degree (i.e. MD, PharmD, PhD) and 10+ 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
• Thorough knowledge of GMP, SOPs and quality control processes
• Thorough knowledge of technical writing for BLA, IND.
• Identifying, writing evaluating and closing OOS’s and investigations
• Thorough 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 in a self-guided manner with scientific/technical personnel.
• Comfortable in a adaptable 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

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The salary range for this position is: $209,865.00 - $271,590.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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