Skip to main content

This job has expired

You will need to login before you can apply for a job.

Senior Director, Global Quality Compliance

Employer
Kite Pharma
Location
Santa Monica, CA, United States
Start date
Aug 12, 2019

View more

Discipline
Quality, Quality Control, Regulatory, Legal/Compliance
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Beach
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 for the role of Senior Director, Global Quality Compliance to work in this exciting new area of cancer immunotherapy. This position will report into the Executive Director Quality, Quality Site Head and be based in Santa Monica, CA.

The successful candidate will be a subject matter expert in Global Regulatory Compliance requirements for GxP environment and will lead and manage a team. You will be responsible to develop and create /approve Company GxP Quality standards, policies, practices and procedures for Kite's GxP activities globally. You will also be a strategic leader and will provide consistent, effective and compliant oversight of GxP activities which will include direct interaction with regulatory authorities, and influencing policies/guidance documents forward-looking in the cell/gene therapy space.

As a Compliance expert, you will partner with Regulatory, Product Quality Leader, Operating Team Leader, Site Quality Heads and Compliance Site Leaders, Manufacturing Leaders, Supply Chain Leaders, and Product Science Leaders.

Responsibilities (include but are not limited to):

Develop and manage the compliance standards for Kite Pharma

Develop and manage monitoring systems for board of health regulations and guidance applicable to Kite Pharma.

Provide strategic compliance positions and communications plan for complex issues with Kite's cell and gene therapy products

Establish and execute industry/regulator influencing compliance positions enabling Kite's leadership position in cell/gene therapy

Develop and run the overall Kite board of health inspection readiness and inspection processes.

Provide metrics and compliance status of all GxP areas within Kite Pharma and with our GxP contracted service providers

Develop and manage compliance and monitoring systems for our apheresis and treatment centers and associated service and logistical suppliers.

Gather metric information for use in continuous improvement of areas of responsibility.

Provide technical writing for various board of health (FDA, EU and ROW) submissions and amendments. Perform other duties as required.

Provide oversight to the Surveillance & Audi program for the company.

Provide oversight, partner and collaborate with Regulatory in communication to board of health globally

Establish a process for global review of regulatory inspection responses globally.

Skills/Qualifications:

Ph.D., MS or MBA preferred with minimum 10 years, or BS with 15+ years of quality, regulatory CMC and management experience in commercial biologics.

Experience with FDA and EU audits, hosting or participating in audits is required.

Experience in managing board of health submissions, meetings, and follow up.

Expert in US FDA and EU biologics regulations and guidance to industry.

Expert in managing US FDA and EU board of health inspections, inspection processes and follow up. Expert in quality systems.

Expert in auditing (audit certification preferred), follow up and discrepancy resolution.

Strong knowledge of GMP, GCP and GLP, SOPs and quality processes. Identifying, writing evaluating and closing investigations.

Strong technical writing skills.

Equipment, facility, instrument IQ/OQ/PQ/PV knowledge.

Proficient in MS Word, Excel, Power Point and other applications.

Strong written and verbal communication skills.

Experience in pharmaceutical, biologics, or CMC industry science organization, engaging in interest groups or authoring technical/compliance positions, is preferred

Ability to communicate and work independently with scientific/technical personnel.

IND123

#LI-ZN1

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.

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 contactcareers@gilead.comfor assistance.

For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert