Manager, Quality Operations

Kite Pharma

1d

About The Position

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.

Requirements

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience OR PhD / PharmD

Nice To Haves

• 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
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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%

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees