Global Quality Lead Solutions Partner
il y a 4 semaines
Our partner is looking for a Global Quality Lead Solutions Partner to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. Job description
- Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
- Maintenance and lifecycle management of QA product flows
- Audits and Inspection readiness
- Product metrics
- Review of Annual Stability Plan
- SOPs and other control documents writing, review and approval as needed
- Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
- Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
- Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
- Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
- Product Impact Assessment as required to support deviations and investigations.
- Interface with Medical Information Team and prepare answers to their requests and questions related to the product in scope.
- Product Quality Complaint Committee preparation and complaints oversight
- Product recall and product escalation meeting preparation
- Annual report (i.e., reporting of change controls to Health authorities…)
- Yearly Biological Product Report
- Reviewer and approver of Global Specification for the accountable products
- Reviewer and approver of Master BoM (Bill of Materials)
- Act as the backup of GQL as needed
- Minimum Level of Education Required - Bachelor’s Degree
- Minimum of 5-10 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience with biotechnological and/or aseptic processes, GMP in Quality, Manufacturing, or Quality Control would be an asset.
- Fluent and confident use of English language verbally and in reading & writing.
- Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
- Must be able to work autonomously for the assigned activities with limited supervision.
- Must be skilled and experienced in operating across cultures and in a multi -cultural environment.
- Must be able to independently analyze data and information to draw conclusions and make effective decisions.
- Must have the ability and agility to adapt to different type of products, tasks and Quality Leads in a collaborative mindset.
- Must be able to identify and suggest harmonization and synergies opportunities to improve ways of working across global products.
- Must be able to deliver presentations or reports adapted to the audience.
- Must possess good interpersonal, verbal, and written communication skills.
- Must have ability to identify risks and propose corrective actions within areas of expertise.
- Experience in GMP audits and inspections would be an advantage.
- Project management skills would be an asset.
- Experience in Data Integrity assessment would be an asset.
- Understanding of CMC Regulatory requirements is a must
-
Global Quality Lead Solutions Partner
il y a 4 semaines
Braine-l'Alleud, Belgique Jefferson Wells Temps pleinLocation: **Braine-l'Alleud** **#24297** **Global Quality Lead Solutions Partner**: Brabant Wallon - contracting Our partner is looking for a **Global Quality Lead Solutions Partner** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. **What are your...
-
Biotech Quality Partner
il y a 1 mois
Braine-l'Alleud, Wallonie, Belgique Randstad Temps pleinWe are looking for a Biotech Quality Partner for one of our clients based in Braine-l'Alleud.Don't hesitate to contact me : - Life Sciences Wallonie.Project contract until end December 2024.key responsibilitiesThis position closely collaborate with the Global Quality Lead (GQL) relative to Quality Assurance activities associated with the lifecycle...
-
Clinical Quality Lead
il y a 1 mois
Braine-l'Alleud, Belgique UCB Temps plein**Make your mark for patients** We are looking for a **Clinical Quality Lead** who is cooperative, insightful and quality-minded to join us in our **Quality Assurance **team, based in either our **Raleigh - NC or Brain - Belgium** office locations. **About the role** As part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is...
-
Asset Quality Lead
il y a 2 semaines
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsWe are looking for a Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is...
-
Asset Quality Lead
il y a 2 semaines
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsWe are looking for a Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by...
-
Clinical Quality Lead
il y a 1 mois
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsWe are looking for a Clinical Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh- NC or Brain - Belgium office locations. About the roleAs part of the Global Quality Assurance Organization, the Clinical Quality Lead (CQL) is responsible to create...
-
Quality Partner Center of Expertise
il y a 4 semaines
Braine-l'Alleud, Belgique UCB S.A. Temps plein**Make your mark for patients** To strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Global Quality Products, Quality Partner, Centre of Expertise based in Braine l’Alleud, Belgium. At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe...
-
Empower Solution Lead
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsAbout the RoleWe are seeking an Empower Solution Lead with a demonstrated experience with Empower solution and passion for cross-functional teams and project management to join our dynamic team at Braine QC Labs, based in our office in Braine-l'Alleud, Belgium. Who You'll Work WithYou'll be an integral part of a diverse and...
-
Empower Solution Lead
il y a 3 jours
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsAbout the RoleWe are seeking an Empower Solution Lead with a demonstrated experience with Empower solution and passion for cross-functional teams and project management to join our dynamic team at Braine QC Labs, based in our office in Braine-l'Alleud, Belgium. Who You'll Work WithYou'll be an integral part of a diverse and...
-
Quality Risk Management Lead
il y a 1 mois
Braine-l'Alleud, Belgique UCB S.A. Temps plein**Make your mark for patients** To strengthen our **Quality Assurance team, **we are looking for a high caliber, self-motivated**, **Quality Risk Management Lead** based in **Braine l’Alleud, Belgium.** **At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do...
-
Vendor Quality Support
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique Randstad Temps pleinWe are looking for a Vendor Quality Support, for one of our clients based in Braine-l'Alleud/Wavre.Don't hesitate to contact me : anne- - Life Sciences Wallonie.This is a contract as a Consultant (employee or freelance). responsabilitésAs a Vendor Quality Specialist, here are the tasks: Review annual stability protocol and reports. Communicate any trends to...
-
Quality Partner Center of Expertise
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Global Quality Products, Quality Partner, Centre of Expertise based in Braine l'Alleud, Belgium. At UCB everything we do starts with a simple question: "How will this make a difference to the lives of people living with severe diseases?"...
-
Quality Partner Center of Expertise
il y a 5 jours
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsTo strengthen our Quality Assurance team, we are looking for a high caliber, self-motivated, Global Quality Products, Quality Partner, Centre of Expertise based in Braine lâAlleud, Belgium.  At UCB everything we do starts with a simple question: âHow will this make a difference to the lives of people living with...
-
Commercial Device Quality Lead
il y a 4 semaines
Braine-l'Alleud, Belgique UCB S.A. Temps plein**Make your mark for patients** To strengthen our **Quality Assurance** **team**, we are looking for a high caliber, self-motivated**, Commercial Device Quality Lead **based in **Braine l’Alleud, Belgium.** **At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We...
-
IT ERP Solution Expert BM/QM
il y a 5 jours
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsTo strengthen our Information Technology team, based in Braine-lâAlleud, Belgium we are looking for a talented individual to fill the position of: IT ERP Solution Expert BM/QM.About the role:Creating valuable, unique solutions for our patients, our employees and other stakeholders is our core at UCB IT. We...
-
IT ERP Solution Expert BM/QM
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Information Technology team, based in Braine-l'Alleud, Belgium we are looking for a talented individual to fill the position of: IT ERP Solution Expert BM/QM.About the role:Creating valuable, unique solutions for our patients, our employees and other stakeholders is our core at UCB IT. We continue to push the bar...
-
Solution Lead
il y a 4 semaines
Braine-l'Alleud, Belgique BAXTER Temps plein**This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Global Development Supply Lead
il y a 1 mois
Braine-l'Alleud, Belgique UCB S.A. Temps plein**Make your mark for patients** To strengthen our, we are looking for a high caliber, self-motivated, Global Development Supply Lead based in Braine l’Alleud, Belgium At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking...
-
GDC Technology Lead Early Solutions
il y a 4 jours
Braine-l'Alleud, Wallonie, Belgique UCB Temps pleinMake your mark for patientsTo strengthen our Information Technology team, based in Braine-l'Alleud, Belgium Belgium, we are looking for a talented individual to fill the position of: GDC Technology Lead Early Solutions. About the role:Prepare the future for UCB Research & Development department infrastructure, called Early Solution, by collaborating with...
-
Primary Packaging Quality Lead
il y a 5 jours
Braine L'alleud, Belgique UCB Temps plein Make your mark for patientsWe are looking for a Primary Packaging Quality Lead to join us in our Devices and Wearable Tech. Quality team, based in our office in Bulle, Switzerland. About the roleThis global position drives operational Quality Assurance activities for development and commercial activities related to Primary packaging (stand-alone or...
