Gilead Sciences, Inc. Senior Manager Document Control - EU in Amsterdam, Netherlands

For Current Kite Pharma Employees and Contractors:

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

Job Description

About Kite Pharma, 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.

We are seeking a highly motivated individual to join us as a Senior Manager Document Control EU. You will work with the Quality Systems team in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Director of Quality Systems in EU.

Responsibilities:

  • The Senior Manager Document Control EU will provide oversight of Kite’s clinical GMP Document and Records Management system. This position will be located at Kite’s manufacturing site in Hoofddorp, and will establish the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools.

  • Additional job duties include:

  • Manage document control processes and systems for GMP activities in compliance with internal procedures and policies as well as regulatory requirements.

  • Manage the routing, review, approval, distribution and archival of new and revised controlled documents.

  • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.

  • Establish and maintains records management system including secure storage, retrieval, retention and destruction.

  • Develop and deliver training and/or site guidance on document and records management roles, and processes.

  • Define resource requirements; assign resources to tasks; manage assigned team.

Requirements:

  • Bachelor’s degree preferred or minimum of 10-12 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

  • Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).

  • Minimum of 3-5 years of management experience.

  • Strong knowledge of GMP, SOPs and quality systems.

  • Excellent writing and editing skills.

  • Works on multiple assignments in collaboration with various department system owners.

  • Advanced skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.

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

  • 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.

More information?

If you want to apply, please do so using the "apply' button. Would you like to know more before you apply? Please contact me, Janne Bruntink - talent acquisition specialist, via: careersEU@kitepharma.com. Or call our recruitment desk: +3120 237 43 91.

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