Gilead Sciences, Inc. Site Qualification Manager, Quality Assurance in Amsterdam, Netherlands

For Current Kite Pharma Employees and Contractors:

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

Job Description

As manager QA – Site Qualification you will be responsible for the qualification of all medical apheresis and treatment centers.

Kite, A Gilead Company

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 Europe is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. We’re building a state-of-the art manufacturing site in the Netherlands (Amsterdam-Hoofddorp).

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As site qualification manager you’ll be joining a newly formed Technical Operations team in Amsterdam, in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity.

You’ll be reporting to the senior director quality.

Your Responsibilities

In this role, you will work cross functionally to assist with the development and implementation of a qualification and monitoring program for medical apheresis and treatment centers that supports Kite’s rapid expansion of our first commercially marketed cell therapy product in the EU.

Your responsibilities, among others, will be:

  • Assist in management of the collection app system.

  • Assess and approve any changes to collection app, 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 that will use 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 selection 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.

  • Assist in management of the collection system.

  • Assess and approve any changes to collection app, courier tracking, order intake and order processing systems to assure validated state of the systems is maintained

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

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

  • Perform other duties as assigned

Your Profile

The ideal candidate for this position is flexible, has great communication skills and feels comfortable in a fast paced environment.

Education

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

Knowledge/Experience

Required:

  • Relevant experience in and extensive knowledge of cGMP

  • Proficiency in English and local language

  • Relevant 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.

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

Preferred:

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

  • Proficient in MS Word, Excel, and Power Point

  • Relevant experience working in multicultural and cross functional teams

Personal skills

Required:

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

  • Team player

  • 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.

Additional Requirements

  • Ability to travel up to 40%

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us.

Apply now!

Would you like to know more before you apply? Please contact Janne Bruntink, Talent Acquisition Business Partner], via: CareersEU@kitepharma.com .

Only candidates in possession of a valid EU work permit will be considered.

Recruitment agencies: We seldom make use of agencies, and when we do, we have a PSL in place. We would appreciate if you did not contact hiring managers or the recruitment team directly, since we will not be able to respond to you.

#LI-JB1

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 .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead