Manager Cell Collection and Rp - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

- inspectorate. The RP will need to be prepared upon short notice to communicate with the Belgium Inspectorate as well as with site physicians on compliance and apheresis starting materials, respectively.

Given the central role in the organization, colleagues that able to naturally foster strong partnerships with other groups are most influential, e.g. in reducing our supply base and achieve operational excellence goals.

Responsibilities:

Builds, shapes and maintains Global Cell Collection network to ensure reliable, available and costeffective operations supporting our patients
Facilitates and conducts technology transfers and training for sites within EMEA, shaping the EMEA network
Refines and executes site selection, qualification, and onboarding activities
Has indepth knowledge of apheresis, cellular processing, and medical knowhow
Executes issues management, risk management and change management
Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external)
Responsible Person for Tissue Establishment ('intermediate structure') under Belgium law (wet MLM)
Accountable for successful inspection by Belgium authorities
Acts as primary point of contact for FAGG
Drives issues management and risk management

Qualifications:

A Medical Degree (MD) with clinical experience in hematology and/or cellular therapies
Hospital and specifically tissue establishment or cell bank experience required
A minimum of 5 years of experience in a pharma, hospital or blood bank environment is required
In depth knowledge of cGMP and the EU Tissue and Cell Directives is required, as well as knowledge of the applicable Belgium laws (such as wet MLM) or the willingness to learn quickly
Fully proficient in the European Regulations and Directives, supplemented with knowledge of the JACIE standards and licensing requirements
Ability to effectively work in multinational teams and enjoys a multicultural environment
Project Management skills and the ability to interface crossfunctionally with clinical and manufacturing personnel is required
Understanding of drug development and submission requirements is preferred
Manufacturing and logistics understanding/experience is preferred
Experience working independently and in a matrixed team environment is required
Has demonstrated to be able to make decisions independently; an innovative and strategic thinker with broad vision is key for this job
Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
Ability to communicate clearly and effectively with all levels of the organization
Ability to summarize and present results, and experience with teambased collaborations is a must
Ability to manage an ambiguous environment and work with a sense of urgency
In addition to fluent English, able to read, write and speak one additional European language
Travel may be required up to 10% of time
Eligible to work in Belgium