QA Team Lead

3 months ago

Stevenage, United Kingdom Rentschler Biopharma SE Full time

Rentschler Biopharma ist ein führendes Auftragsentwicklungs
- und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschließlich Projektplanung und regulatorischer Unterstützung an. In Stevenage, UK, haben wir das auf Zell
- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegründet.

Wir sind ein Familienunternehmen mit rund 1.400 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft für das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen.

Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfügbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche

Tasks and Responsibilities:

- Support with the continuous improvement of the Quality Management System (QMS)
- Work to maintain all aspects of the QMS e.g. Change Controls, Non-Conformities, CAPAs, Deviations
- Provide all relevant support required by the Operations teams.
- Perform internal audits, self-inspections & walk arounds, and assist with on-site audits of external suppliers when required.
- Lead on training of new personnel on all aspects related to the QMS.
- Collection and reporting of monthly Quality KPIs
- Develop, collaborate and implement policies, SOPs, work instructions etc.
- Participate in Continuous Improvement (CI) activities and projects through challenging current working practices with a view of improving efficiencies and Quality standards.
- Responsible as Technical project Lead for external client projects and internal projects, liaising with Project management and other higher management to make key decisions of the project.
- Technical and project-specific support to address customer queries and participate as SME in client meetings.
- Line Management of team of Quality Assurance associates, including recruitment, training and coaching of the team.

What Is Important To Us:

- A degree (or equivalent) in the life sciences or related field.
- At least 5 years’ experience in Quality supporting the GMP manufacture of small to large molecules.
- Demonstrate working with internal (Manufacturing, QC, Supply Chain) and external stakeholders on all areas of quality and compliance.
- Good communication skills with the ability to liaise with internal and external stakeholders providing a credible interface, managing expectations and dealing with complex problems.
- Showing initiative and a proactive mentality in executing plans and delivering objectives. Problem solving mindset.
- Experience with viral vectors, experience with AAV would be advantageous.

What We Offer
- Employment in a company that offers real added value and manufactures medicines for seriously ill patients.
- To be part of the ATMP growth and success story, participating in the development of a great company culture based on teamwork, empowerment and opportunity for personal growth.
- A holiday entitlement of 28 days plus public holidays.
- Flexible working conditions
- An above market pension provision increasing with length of service.
- Private medical health care and benefits scheme.
- Plus other additional benefits.

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