QA Team Lead

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!

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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