Gene Therapy Operations Manager
il y a 6 jours
About the Role:
">This Gene Therapy Operations Manager will support the Genesis project GMP Readiness program to timely obtain health authorities' authorization to manufacture Gene Therapy clinical batches in a new facility pilot plant.
Key Responsibilities:
- Drive the implementation of new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
- Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
- Manage materials and product specifications, execute incoming materials release.
- Contribute to the consolidation and writing of the Contamination Control Strategy.
- Drive supplier qualification programs.
- Establish and drive inspection readiness programs.
- Prepare the new Gene Therapy Facility Site Master File.
Requirements:
- Scientific master's degree or equivalent.
- At least 5-8 years of QA oversight experience in a GMP manufacturing environment.
- Experience with new manufacturing facilities seeking Health Authorities certification.
- Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing.
- Experience in health authorities' inspections.
- Strong knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing.
- Fluency in English and French.
- QP Registration in Belgium is an asset.
- Demonstrated ability to collaborate with senior stakeholders.
- Strong understanding of risk-based approaches.
- Able to understand customers' needs and technical requirements.
-
Gene Therapy Quality Partner
il y a 4 semaines
Braine-l'Alleud, Wallonie, Belgique CareerWallet Temps pleinContracting – Brabant Wallon As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant. Drive the implementation of the new Gene Therapy facility quality operational procedures into existing...
-
Gene Therapy Quality Partner
il y a 2 semaines
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Temps pleinContracting – Brabant Wallon As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant. Drive the implementation of the new Gene Therapy facility quality operational procedures into existing...
-
Gene Therapy Quality Partner
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Temps pleinContracting – Brabant Wallon Job description As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.Drive the implementation of the new Gene Therapy facility quality operational procedures...
-
Gene Therapy Quality Partner
il y a 2 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinSocial network you want to login/join with:Gene Therapy Quality Partner, Braine-l'AlleudClient:Jefferson WellsLocation:Braine-l'AlleudJob Category:OtherEU work permit required:YesJob Reference:8d4e2dd3f41eJob Views:3Posted:23.03.2025Expiry Date:07.05.2025Job Description:Contracting – Brabant WallonAs a Gene Therapy Quality Partner, you will support the...
-
Gene Therapy Quality Assurance Lead
il y a 3 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinWe are seeking a Gene Therapy Quality Assurance Lead to join our team at TN Belgium. As a member of the Genesis project, you will play a critical role in ensuring the timely approval of our Gene Therapy clinical batches by health authorities.Main Objectives:Lead the development and implementation of quality operational procedures into existing QMS...
-
Regulatory Compliance Expert in Gene Therapy
il y a 6 jours
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps pleinAbout This OpportunityWe are looking for a skilled professional to fill the role of Gene Therapy Facility Implementation Manager. As a key member of our team, you will be responsible for driving the implementation of new Gene Therapy facility quality operational procedures into existing QMS.Your Key ResponsibilitiesDrive the implementation of new Gene...
-
Gene Therapy Quality Partner
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps pleinGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Jefferson Wells BelgiumLooking for skilled professionals within Life Sciences | Talent Acquisition Specialist at Jefferson WellsGene Therapy Quality PartnerYour responsibilities:- Drive the implementation of the new Gene Therapy facility quality operational...
-
Gene Therapy Quality Expert
il y a 2 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinAs a Quality Partner at TN Belgium, you will be instrumental in supporting the Genesis project's GMP Readiness program to ensure timely authorization for manufacturing Gene Therapy clinical batches in our new facility pilot plant.ResponsibilitiesImplement new quality operational procedures into existing QMS (change control, deviation management, release...
-
Gene Therapy Facility Implementation Manager
il y a 6 jours
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps pleinJob DescriptionAs a Regulatory Compliance Expert in Gene Therapy, you will be responsible for implementing new Gene Therapy facility quality operational procedures into existing QMS. You will support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.About UsJefferson Wells Belgium is a leading...
-
Gene Therapy Compliance and Excellence Lead
il y a 4 semaines
Braine-l'Alleud, Wallonie, Belgique UCB S.A. Temps pleinMake your mark for patientsWe are looking for a Gene Therapy Compliance and Excellence Lead who is experienced, detail-oriented, and proactive to join our Process Compliance and Excellence Team, based at our UCB campus in Braine-l'alleud, Belgium.About the RoleYou will be responsible for ensuring Good Manufacturing Practices (GMP) operations compliance and...
-
Quality Assurance Specialist
il y a 1 jour
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinTN Belgium invites highly skilled professionals to support the Genesis project's GMP Readiness program as a Quality Assurance Specialist - Gene Therapy.About the RoleCollaborate with cross-functional teams to implement new quality operational procedures.Support the assessment of GMP & Operations Readiness program progress.Ensure compliance with regulatory...
-
GMP Readiness Program Manager
il y a 3 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinTN Belgium is seeking a GMP Readiness Program Manager to lead the Genesis project. As a specialist in Gene Therapy quality assurance, you will ensure the successful preparation and execution of our Gene Therapy clinical batches.Key Responsibilities:Develop and implement quality operational procedures into existing QMS systems.Assess the GMP & Operations...
-
GMP Readiness Program Specialist
il y a 6 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinAbout TN Belgium:">We are looking for a highly skilled Biopharmaceutical Quality Assurance Expert to join our team as a Gene Therapy Quality Partner. In this role, you will support the Genesis project GMP Readiness program to timely obtain health authorities' authorization to manufacture Gene Therapy clinical batches in a new facility pilot plant.Your Key...
-
Biopharmaceutical Quality Assurance Expert
il y a 6 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinAbout the Position:">The Biopharmaceutical Quality Assurance Expert we are looking for will be responsible for supporting the Genesis project GMP Readiness program to timely obtain health authorities' authorization to manufacture Gene Therapy clinical batches in a new facility pilot plant.Main Responsibilities:Support the implementation of new Gene Therapy...
-
Biopharmaceutical Manufacturing Specialist
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps pleinAs a Biopharmaceutical Manufacturing Specialist at TN Belgium, you will be responsible for supporting the Genesis project GMP Readiness program. This program aims to obtain health authorities' authorization to manufacture Gene Therapy clinical batches in our new facility pilot plant.Key Responsibilities:Drive the implementation of quality operational...
-
Biopharmaceutical Quality Assurance Specialist
il y a 6 jours
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps pleinJob OverviewWe are seeking a highly skilled Biopharmaceutical Quality Assurance Specialist to join our team at Jefferson Wells Belgium. As a key member of our organization, you will be responsible for driving the implementation of new Gene Therapy facility quality operational procedures into existing QMS.About the RoleThis is an exciting opportunity to work...
-
Hydrogen Operations Manager
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique Virya H2 Temps pleinAt Virya H2, we are shaping the future of hydrogen production. Our team is dedicated to developing a growing portfolio of hydrogen production plants across Belgium and the Netherlands. We combine cutting-edge production development with innovative infrastructure solutions through our refueling network, while actively establishing strategic partnerships with...
-
Quality Assurance Manager Laboratory Operations
il y a 16 heures
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Belgium Temps plein**Job Description**We are looking for a Quality Assurance Manager Laboratory Operations to oversee laboratory operations and ensure compliance with regulatory requirements.**Key Responsibilities:**Oversight of laboratory operations and production pilotsEnsure correct completion of 'issued Copy' processCoordinate development local instructions and liaise with...
-
Quality Operations Manager
il y a 7 jours
Braine-l'Alleud, Wallonie, Belgique TN Belgium Temps plein**About the RoleWe are seeking a seasoned Quality Operations Manager to join our Development Quality Team in Braine-l'Alleud. As a key member of the team, you will play a critical role in ensuring the effective establishment, implementation, and maintenance of a Quality Management System (QMS) that supports product development.Key Responsibilities:Drive...
-
GMP Quality Lab Operations Manager
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique Jefferson Wells Manpower Group Temps pleinAbout the Position:We are looking for a highly skilled GMP Quality Lab Operations Manager to join our team in Walloon Brabant. As a key member of our Clinical Manufacturing Quality team, you will be responsible for ensuring the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to...