QA Release Supervisor

il y a 1 semaine


Gent, Flandre, Belgique MindCapture Temps plein

QA RELEASE SUPERVISOR

  • Biotechnology
  • GhentABOUT THE COMPANY


The
QA Release Supervisor holds a pivotal role, ensuring the quality oversight of personalized cell therapy production for both clinical and commercial requirements within a sterile GMP environment.

This position involves supervising QA release associates, collaborating with manufacturing to troubleshoot issues, and working in a shift regime to support continuous production.


Key Responsibilities:

  • Ability to read, interpret and revise documents such as SOPs, work instructions.
  • Develop positive relationship with the QA teams, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
  • Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
  • Independently makes appropriate and compliant GMP decisions.
  • Independently resolves problems through the use of quality systems.
  • Develop improvement ideas and independently implement associated solutions.
  • Support QA team development.
  • Possess the ability to positively influence peers, key stakeholders and management.
  • Generates shift schedules, to ensure efficient coverage for all operational needs.
  • Maintain individual training completion in a compliant state.
  • Supports the completion of corrective and preventive actions, as necessary.
  • Supports internal/external audits.
  • Supports Quality risk assessment teams.
  • Review/approve documents as a Quality Subject Matter Expert (SME).
  • Remain current in skills and industry trends.
  • Detailed knowledge of Quality and Compliance standards.
REQUIRED COMPETENCES & SKILLS

Education:

A minimum of a Master's Degree in Science or equivalent technical discipline is required.

Experience:

  • Minimum 6 years of relevant work experience.
  • Preferably experienced in an aseptic manufacturing facility, particularly in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
  • Minimum 2 years of experience with quality support in GMP manufacture is preferred.
  • Minimum 1 year of leadership experience is required.

Key Capabilities, Knowledge, and Skills:

  • Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to manufacturing cellbased products.
  • Strong interpersonal and written/oral communication skills.
  • Ability to process complex information and make critical decisions with limited information.
  • Highly organized, capable of working in a team environment, and positive attitude under supervision.
  • Good written and verbal communication skills.
  • Experience directly supervising employees is preferred.

  • QA Release Specialist

    il y a 1 semaine


    Gent, Flandre, Belgique MindCapture Temps plein

    QA RELEASE SPECIALIST Biotech GentWHAT IS OFFEREDBe part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.ABOUT THE COMPANYMindCapture supports in the recruitment of this...


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Sr QA Associate for the CAR-T hub in Europe. The position will be based in Ghent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T cells and are...

  • QA Specialist

    il y a 1 semaine


    Gent, Flandre, Belgique Nuwhï Temps plein

    About the role of QA SpecialistDepending on your level of experience, you collaborate on or lead the management of projects or operational services linked to quality assurance system of various clients (pharma, biotech, medtech), such as:Deviations, CAPA, Change Control, OOS management; Supplier/Vendor management; PQR writing/reviewing; Audit management;...

  • Sr QA Associate Car-t Emea

    il y a 1 semaine


    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Flexible work practices, award-winning benefits This position will be based in Ghent, Belgium.Change lives for the better.THE OPPORTUNITYHow you can help.Johnson & Johnson (J&J) is recruiting a Sr QA Associate, QA Operations Lead for the CAR-T hub in Europe. The position will be based in Ghent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an...


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a QA/QP Support Lead for the CAR-T hub in Europe. The position will be based in Ghent, Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells....


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe.- CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients'...

  • QA Lead Investigations

    il y a 1 semaine


    Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a QA Operations Lead Investigations, for the CAR-T hub in Europe. The position will be based in Ghent, Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the...


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe. The position will be mainly based in Ghent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own...


  • Gent, Flandre, Belgique DeLaval Temps plein

    The Product Portfolio Milk Quality & Animal Health (PP MQAH) produces and distributes chemical products by, among others, the Chemicals Division in Drongen (Ghent). The Product Portfolio consists of udder hygiene products, hoof disinfectants and detergents used by dairy farmers around the world.We are currently looking for aJunior Quality Assurance Officer /...

  • Car-t Operations Supervisor

    il y a 1 semaine


    Gent, Flandre, Belgique Legend Biotech EU Temps plein

    Company InformationLegend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.ROLE OVERVIEWThe CAR-T Operations Supervisor is...


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    Flexible work practices, award-winning benefits This position will be based in Ghent, Belgium.Change lives for the better.THE OPPORTUNITYHow you can help.The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA Project Engineer for the CAR-T hub in Europe. The position will be based in Ghent...


  • Gent, Flandre, Belgique Argenx Temps plein

    For the expansion of our BIS team, argenx is looking for a (Senior) Manager Application Validation and Quality.The (Senior) Manager Application Validation and Quality is responsible for the day to day operations and coordination of all activities relating to the argenx Computer Systems Validation (CSV) Process. This ranges from Initial Impact Assessment,...

  • IT Quality

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    Argenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development...

  • Technical Lead Clean Room

    il y a 1 semaine


    Gent, Flandre, Belgique MindCapture Temps plein

    TECHNICAL LEAD CLEAN ROOM Biotech GhentABOUT THE COMPANYThe Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations. This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering,...

  • Senior Director BIS Quality

    il y a 1 semaine


    Gent, Flandre, Belgique argenx SE Temps plein

    Senior Director BIS Quality page is loaded Senior Director BIS Quality Apply locations Gent Boston time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2082 As argenx continues to grow and evolve, we are looking for a Senior Director BIS Quality. The Senior Director BIS Quality is responsible for both the strategic direction as well as...

  • Product Quality Manager

    il y a 1 semaine


    Gent, Flandre, Belgique Argenx Temps plein

    As part of the Product Quality organization, this function will drive operational quality assurance activities at key vendors for commercial biological drug products and plays a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams.ROLES AND RESPONSIBILITIES:In close collaboration with vendors,...


  • Gent, Flandre, Belgique Johnson & Johnson Temps plein

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the...

  • Technical Product Owner

    il y a 1 semaine


    Gent, Flandre, Belgique iController Temps plein

    What You'll Do: Perform analysis of the functional and nonfunctional (ex. legal) requirements the new features: connections to external partners, improvements, and updates of existing connections Work with official governmental/tax authority/regulatory documentation to elucidate the requirements Work closely with stakeholders to clearly define what will be...

  • Administrative Support

    il y a 1 semaine


    Gent, Flandre, Belgique Page Personnel Temps plein

    Added 29/04/202- Be part of an amazing company that impacts/saves the lives of thousands Great opportunity to contribute and learn a lotAbout Our Client:Our client is a well-known, international-oriented, company that focuses on creating new therapies for patients all over the world. Thanks to their strong R&D and state-of-the-art facilities they are...

  • Group Leader Formulation

    il y a 1 semaine


    Gent, Flandre, Belgique Ardena Temps plein

    About usAs a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio...