Manager, Quality Operations

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come

Kite is seeking a highly motivated, self-driven individual to join the North America Regional Quality Operations team as Manager, Quality Operations in the exciting new area of CAR-T cancer immunotherapy. You will work cross functionally to assist with the qualification and monitoring program for apheresis collection and treatment centers that supports Kite’s rapid expansion of our commercially marketed cell therapy product.

There are 2 openings for this role.

Job Responsibilities:

• Assess and approve any changes to Apheresis Collection Module, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained.

• Assist in the management of an apheresis and treatment center (ATC) qualification process using risk-based tools for qualification, training, monitoring and disqualification.

• Collaborate with our Commercial operations in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes.

• Perform a variety of audits, qualify and monitor compliance to qualification requirements.

• Maintain the monitoring schedule and approved ATC list.

• Assist with resolution of ATC and courier issues and discrepancies, and the investigations to resolve the issues.

• Support and/or own quality records (Deviations, CAPA, Change control, etc.)

• Assist in development, implementation and management of ATC management system (GVault)

• Support inspection readiness plans and interact with regulatory agencies during inspections on ATC-related matters, as needed.

• Ability to travel up to 40%  

Basic qualifications:

Bachelor's Degree and Six Years' Experience

OR

Masters' Degree and Four Years' Experience

OR

PhD / PharmD

Preferred Qualifications:

• Bachelor’s degree in biological sciences, nursing, medical technologist or related field

• 8 years progressive experience in a medical or pharmaceutical environment, including nursing, apheresis/transplant/infusion centers, or blood banks, preferred; OR pharmaceutical, vaccines or biologics quality systems’ roles.

• Minimum 3-5 years quality assurance experience preferred

• Experience managing external suppliers, blood banks, and plasma centers.

• Medical center or pharmaceutical auditing experience preferred.

•  Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.

• Previous experience in deviation management, development of corrective preventive/actions and change control, preferred.

• ASQ Certified Quality Auditor preferred

• Strong working knowledge of and the ability to apply GMP and FACT/AABB standards

• Previous experience presenting and responding to regulatory agency or certification audits, preferred

• Proficient in MS Word, Excel, and Power Point

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

• Must be able to work independently, can multi-task and prioritize job responsibilities