QA System Lead
il y a 2 semaines
**Position Summary**
Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to lead optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill 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 Sytem Lead**
**The Role**
The QA System Lead will ensure the maintenance and the improvement of the Quality Management system and the compliance with applicable US/EU regulations, guidances and company policies/procedures.
- Global _
The QA System Lead is an active member of QA System Department and will be accountable as Subject Matter Expert and leader, providing guidance for the following systems:
- Document and record training
- Complaints
- Audits
- CAPA/Deviations
- Change control
- Risk assessment
- Quality _
In life cycle phase, the QA System Lead is focus in the maintenance of the following system:
- Pharmaceutical Quality System
- Update, in compliance with the current regulation the QA quality system documents.
- With the collaboration of concerned department, establish annually the Annual Quality Review (AQR)
- Review, challenge and approve, in compliance with GMP, Deviation, CAPA, Complains, Audits, Change Control, Risk
- Update, analyze the process of deviation, capa, change control, risk analysis with KPI. Propose and realize adapted action.
- Ensure the internal audit program is compliant to current regulations as required. Plan, coordinate (scheduling, and reporting) and perform audits of the plant systems and procedures.Update and take adapted action to ensure the CAPA follow up
- Self Inspection
- Update and realise the Self Inspection quality system documents and take adapted action to ensure the CAPA follow up
- Quality Risk Management
- Update and take adapted action to maintain the Risk Management quality system documents.
- Continuous Improvement
- Implement pertinent tools of operational excellence “Lean culture”
- Implements and follows-up Key Performance Indicators
- People_
- Participate to meeting related to QA System
- Implement an empowerment culture.
- Maintains opened and effective communication with all other department.
- With the collaboration of the training department point of contact, he gives QA training related to his activity to the site.
- Lead audit and inspection
- Represent Catalent (customer, external event, audit)
- Perform internal or external audit
- Deliver any kind of leadership and support to the organization
- No people management at this stage
- Master degree or Bachelor degree in biology, pharmacy, clinical chemistry, etc., or relevant experience in a similar position in the sector of Biotech/Pharma/cell therapy
- Experience of minimum - 5 years in Quality, preferably in a biopharmaceutical company
- Good knowledge of cGMP
- Able to manage by influence
- Experience in cGMP audits
- Fluency in French and English is a must (read and understand)
- Computer literate: Microsoft office ( Word, Excel, Power Point), TrackWise and ComplianceWire
- Rigourous, consciencious, flexible and honest
- Critical mind
- Ownership
- Autonomous and organized (good time management skills)
- Efficient communicator, quality minded and customer oriented
- Willing to bring new challenges
- Open minded
- Quality mindset
- Natural Leader and excellent communicator
**Position Benefits**
- Full-time position (40h/week).
- An indeterminate contract.
- Group & health insurance
- Meal vouchers & Eco Vouchers
- Company car
- The opportunity to take part in a growing dynamic biotech company.
- A human-sized working environment with a convivial atmosphere.
**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
**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 des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune s
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