QA Third Party Manager

il y a 7 jours

Gosselies, Belgique Catalent Temps plein

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated **QA Third Party Manager**.

**The Role**
- Manage the QA oversight of the GxP suppliers.
- Act as a back-up of the Deputy Responsible Person - Intermediate Structure/Biobank for tasks linked to the acceptance, release and distribution of the Human Body Materials.
- Ensure the appropriate support to the QA Director regarding the design, effective implementation, monitoring and maintenance of the quality management system of the GMP entity and the Tissue Establishment entity.
- Maintain the Gosselies’s approved suppliers list.
- Perform supplier questionnaire audits.
- Provide supporting data to the Global Supplier Quality Management Team for the performance of on-site or virtual supplier audits.
- Assess supplier notifications of change with internal stakeholders and follow-up until closure.
- Write supplier complaints with internal stakeholders, follow-up with the supplier, assess the response provided by the supplier and close the complaints.
- Write, coordinate, issue and maintain supplier quality agreements.
- Lead the performance of supplier risk assessments.
- Prepare and analyze metrics related to supplier quality management topics: IR score card, Management Review, Annual Quality Review,
- Be the contact point for other Gosselies’ departments in case of questions or training related to the supplier quality management system.
- Present the supplier quality management system during customer audits, regulatory agency inspections, internal audits,
- Closely work with the Global Supplier Quality Management Team in order to implement corporate policies / quality standards in Gosselies’ quality management system.
- Initiate, review or approve quality records (change controls, deviations, ) linked to the supplier quality management system.
- Perform self-inspections/internal audits as a qualified internal lead auditor.
- Participate in the GEMBA walks organized by the QA department.
- Participate in continuous improvement projects linked to supplier quality management at Gosselies’ (Quality Plans, ) and use operational excellence tools.
- Support the Deputy Responsible Person - Intermediate Structure/Biobank in continuous improvement projects linked to the management of Human Body Materials (HBM).
- Ensure that the required initial and continuing training of the QA Third Party team is carried out and adapted according to needs.
- Supervise the activities of the QA Third Party team to achieve their goals.
- Ensure appropriated resources, time and competencies in QA Third Party activities.
- At least Master’s degree or higher and relevant experience in cell and gene therapy.
- Strong organisation skills
- Experience in quality assurance within a similar role
- Ability to multi-task and demonstrate diplomatic and leadership skills
- Demonstrates initiative and ability to meet deadlines
- Excellent verbal and written communication skills to convey and receive ideas and instructions to/from others within the organization
- Ability to effectively present information and respond to questions from peers, management and customers
- Fluency in French: good speaking, reading and writing skills,
- Good reading comprehension and writing skills in English.
- Computer skills: Microsoft office, ETQ, ComplianceWire, TrackWise are a plus.
- Knowledge of existing and emerging social media technologies and channels a plus

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Delivers Results
- Leads with Integrity and Respect
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**Position Benefits**
- Full-time position (40h/week)
- An indeterminate contract
- The opportunity to take part in a growing dynamic biotech company
- A human-sized working environment with a convivial atmosphere
- Health & Group Insurance, meal-vouchers, eco-vouchers, company car.

**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec de

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